Paclitaxel-coated Balloon Catheter Research Articles

DRug-coated Balloon for Endovascular treatment of sYmptOmatic intracraNial stenotic Disease (DR. BEYOND): the protocol of a multicentre randomised trial

BackgroundAlthough endovascular stenting is considered an effective and safe therapeutic option for symptomatic intracranial atherosclerotic disease (sICAD), an elevated rate of restenosis remains an important issue for the conventional bare-metal...

Tactics of Endovascular Treatment of Patients with Coronary Heart Disease with Recurrent Coronary In-Stent Restenosis Using Second- and Third-Generation Stent Systems and Paclitaxel-Coated Balloon Catheters

INTRODUCTION: The binary in-stent restenosis (ISR) still remains the main factor limiting the effectiveness of percutaneous coronary intervention in the long-term period. Histologically, ISR is defined as neointimal hyperplasia leading to hemodynamically significant narrowing of the arterial lumen. Patients with coronary artery (CA) restenosis represent a particularly challenging group for endovascular treatment.
 AIM: To compare effectiveness and safety of the endovascular correction of coronary in-stent restenosis using second- and third-generation stent systems and balloon angioplasty with a drug-coated balloon catheter.
 MATERIALS AND METHODS: The study retrospectively included 62 patients with recurrent ISR after the previous endovascular correction. The patients underwent treatment with re-stenting in Saint George Clinic of Thoracic and Cardiovascular Surgery of the National Pirogov Medical Surgical Center in 2016–2023 with use of second- and third-generation drug-eluting stents — cobalt (cobalt alloy) systems with zotarolimus, cobalt-chromium stent systems with sirolimus and zotarolimus, platinum-chromium stent systems with everolimus with biodegradable drug coating. Balloon angioplasty was performed using paclitaxel-coated balloon catheters. The primary endpoint of the study was the target lesion failure (TLF) of CA. The secondary endpoint was major adverse cardiovascular events (MACE).
 RESULTS: The TLF rate was 15.6% vs. 13.3% and 28.1% vs. 46.7% in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.30). MACE was recorded in 18.8% vs. 16.7% and 37.5% vs. 56.7% of cases in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.25). The dispersion analysis of predictors of TFL risks identified three factors showing a reliable correlation with the probability for TFL by the second follow-up year in both groups: (1) recurrence of binary ISR (hazard ratio (HR) 2.21; 95% confidence interval (CI) 0.95–4.01; p = 0.03)) in 365 days after the third stage of the percutaneous coronary intervention; (2) length of coronary restenotic lesion (per every 10 mm) (HR 1.25; 95% CI 0.99–1.40; p = 0.002); (3) occlusive restenosis (HR 4.16; 95% CI 0.43–26.96; p = 0.04).
 CONCLUSIONS: The implantation of a second- and third-generation drug-eluting stent and balloon angioplasty with use of a drug-coated catheter are comparable in the effectiveness and safety in correcting the recurrent ISR, however, restenting is associated with a lower probability for developing TFL and adverse events.

Usage of rotational atherectomy and drug-coated balloon angioplasty for isolated popliteal artery lesions: two-year results of a retrospective study

Objectives In this study, perioperative properties and early and mid-term clinical outcomes of endovascular revascularization with a combined usage of rotational atherectomy (RA) and drug-coated balloon angioplasty (DCB) angioplasty for isolated popliteal artery lesion were reported. Methods A total of 28 patients with isolated popliteal artery stenosis who underwent combined RA and DCB angioplasty between December 2018 and September 2022 were analyzed retrospectively. Temren atherectomy system (Invamed, Ankara, Turkey) and Extender paclitaxel-coated drug-coated balloon catheter (Invamed, Ankara, Turkey) were used in all cases. The main outcome was primary patency; secondary outcomes were technical success, freedom from amputation, and mortality. Results The mean age of patients was 64.2 ± 9.1 years and the majority of the patients were male (n = 20; 71.4%). Types of the lesions were total occlusion in 24 limbs and critical stenosis in 4 limbs. The mean total occlusion length was 65.2 ± 14.2 mm. Flow-limiting dissection was seen in lesions of 2 patients (7.1%) and treated with prolonged balloon dilatation without bail-out stenting requirement. Technical success defined as an adequate vascular lumen (less than 30% stenosis) was achieved in 26 (92.8%) with a mean follow-up of 17.2 ± 8.2 months. The mean primary patency rates at 12 months and 24 months were 92.3% ± 3.2 and 81.2% ± 3.2, respectively. Complications included 1 distal embolization following RA, 2 flow-limiting dissections, and 3 puncture site hematomas. Conclusions Endovascular procedures using combined RA and DCB angioplasty seem to be effective alternative treatment modalities for the treatment of popliteal artery lesions with high rates of primary patency and freedom from TLR.

Paclitaxel-coated balloon catheter for benign esophageal stenosis in a rabbit model

Most patients with benign esophageal stenosis require multiple or even continuous balloon dilation treatments to achieve symptom relief. In this study, eighteen rabbits were used to establish an esophageal benign stenosis model and were divided into a control group (n = 6), a balloon group (n = 6) and a PTX-coated balloon group (n = 6) to evaluate the feasibility and effectiveness of paclitaxel (PTX)-coated balloons for the rabbit esophageal benign stenosis model. The weight and esophageal diameter were recorded every 2 weeks until 8 weeks post-surgery. Hematoxylin–eosin staining, Masson’s trichrome staining and immunohistochemical staining were performed for pathological analysis. Four weeks post-operation, there was a significant difference in weight between the control group and the balloon group (p = 0.01) and between the control group and the PTX balloon group (p = 0.01). There was a significant difference in the esophageal diameter between the balloon group and the PTX balloon group at 8 weeks post-operation (p = 0.02). Four weeks post-operation, the degree of inflammatory cell infiltration in the PTX balloon group was significantly lower than that in the control group (p = 0.002) and balloon group (p = 0.001). The degree of collagen deposition in the PTX balloon group was significantly lower than that in the control group (p = 0.002) and balloon group (p = 0.03). Eight weeks post-operation, the percentage of cells positive for TGF-β (p < 0.001), the degree of inflammatory cell infiltration (p = 0.02) and the degree of collagen deposition (p = 0.02) in the PTX balloon group were significantly lower than those in the balloon group. Therefore, PTX-coated balloons may alleviate the local inflammatory response and collagen deposition when used during dilation treatment of benign esophageal stenosis.

Safety and Efficacy of the Passeo-18 Lux Drug-Coated Balloon Catheter in Atherosclerotic Femoropopliteal Lesions: The Multicenter BIOLUX P-IV China Study

The purpose of this trial was to assess the safety and effectiveness of a paclitaxel-coated balloon catheter in Chinese patients with de novo or nonstented restenotic femoropopliteal atherosclerotic lesions. BIOLUX P-IV China is a prospective, independently adjudicated, multicenter, single-arm trial conducted in China. Patients with Rutherford class 2-4 were eligible, excluded were patients in which predilation resulted in severe (≥ grade D) flow-limiting dissection or residual stenosis > 70%. Follow-up assessments were conducted at 1, 6, and 12months. The primary safety end point was 30-day major adverse event rate and the primary effectiveness end point was primary patency at 12months. We enrolled 158 patients with 158 lesions. Mean age was 67.6±9.6years, diabetes was present in 53.8% (n=85), and previous peripheral intervention/surgeries in 17.1% (n=27). Lesions were 4.1±0.9mm in diameter and 74±50mm long with a mean diameter stenosis of 91±13%; 58.2% (n=92) were occluded (core laboratory analysis). Device success was achieved in all patients. The rate of major adverse events was 0.6% (95% confidence interval: 0.0; 3.5) at 30days, consisting of 1 target lesion revascularization. At 12months, binary restenosis was present in 18.7% (n=26) and target lesion revascularization was performed in 1.4% (n=2, all clinically driven), resulting in a primary patency of 80.0% (95% confidence interval: 72.4, 85.8); no major target limb amputation occurred. Clinical improvement at 12months, defined as improvement of at least 1 Rutherford class, was 95.3% (n=130). The median walking distance per 6-minute walk test was 279m at baseline and improved by 50m at 30days and by 60m at 12months; the visual analogue scale changed from 76.6±15.6 at baseline to 80.0±15.0 at 30days and 78.6±14.6 at 12months. Our results confirmed the clinical effectiveness and safety of a paclitaxel-coated peripheral balloon dilatation catheter for the treatment of de novo and nonstented restenotic lesion of the superficial femoral and proximal popliteal artery in Chinese patients (NCT02912715).

A pilot study of a novel paclitaxel-coated angioplasty catheter for lower extremity peripheral artery disease: a pilot study.

The aim of the study was to report our preliminary results and real-world experiences regarding the use of a novel paclitaxel-coated balloon catheter in a cohort of patients with lower extremity peripheral artery disease at different stages. A prospective cohort pilot study was conducted and the study group was made up of a total of 20 patients with peripheral artery disease who underwent endovascular balloon angioplasty with BioPath 014 or 035, a novel paclitaxel-coated, shellac containing balloon catheter. Eleven patients had a total of 13 TASC II-A lesions, 6 patients had a total of 7 TASC II-B lesions, 2 patients had TASC II-C lesions, 2 patients had TASC II-D lesions. In 13 patients, a single attempt with a BioPath catheter was adequate to treat a total of 20 target lesions, whereas in 7 patients more than one attempt with a different sized BioPath catheter was necessary. In 5 patients, total or near-total occlusion in the target vessel was initially treated with an appropriate sized chronic total occlusion catheter. Thirteen (65%) patients had at least one categorical improvement in Fontaine classification and none had symptomatic worsening. The BioPath paclitaxel-coated balloon catheter seems to offer a useful alternative to the similar devices for treatment of femoral-popliteal artery disease. These preliminary results warrant confirmation with further research to reveal the safety and efficacy of the device.

Evaluation of a new paclitaxel-coated balloon catheter in an in vivo porcine peripheral venous model: Feasibility, safety, and drug deliverability.

To evaluate in vivo the feasibility, safety, and paclitaxel (PTX) deliverability of a newly developed non-commercially available Paclitaxel-Coated Balloon (PCB) catheter in the swine healthy peripheral vein model. In total 12 PCBs were deployed in 12 venous segments. Primary feasibility endpoint was the successful application of the devices to the veins of the animals. Primary efficacy endpoint was the determination of the drug content in the venous tissue at 24 h and 7 days after balloon expansion, as assessed by analysis of the vein tissue with High Performance Liquid Chromatography (HPLC) coupled with tandem mass spectrometry. Primary safety endpoint was freedom from any major adverse event. Secondary endpoint was the investigation of any independent factor affecting the primary endpoints. Paclitaxel was detected in five out of six tissue samples 24 h post-intervention and five out of six tissues at 7 days following the procedure (10 tissue samples out of 12). The mean weight of tissue that was examined was 0.20604 ± 0.29822 g (range: 1.02823-0.03377 g) and the mean PTX concentration detected was 8.4 ± 13.1 μg/g (range: 0-36.1 μg/g). The average drug content detected at 24 h (17.1 ± 17.1 μg/g) was numerically superior, but non-statistically significant, compared to 7 days (3.1 ± 3.6 μg/g). An average of 33.8% of the drug remained on the balloon after retrieval. According to the multiple linear regression analysis, there was no significant correlation between transition time, PTX remaining on the balloon, time of analysis (24 h/7 days) and PTX tissue concentration. No abnormalities were noted during autopsy. The newly developed PCB successfully delivered within the healthy venous wall a dose of Paclitaxel that inhibits neointimal hyperplasia. No safety issues were raised at short-term follow-up.

Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon

The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents. Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4μg/mm2) with a PCB (SeQuent Please, B. Braun Melsungen; 3μg/mm2). The primary endpoint was angiographic late lumen loss (LLL) at 6months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6months, in-segment LLL was 0.01 ± 0.33mm in the PCB group versus 0.10 ± 0.32mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95%CI:-0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P=0.019). Major adverse cardiovascular events up to 12months also did not differ between the groups. This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364).

Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial.

Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions. The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI). The IN.PACT BTK randomised study is a prospective, multicentre, randomised pilot study. Fifty CLTI participants (Rutherford clinical category 4-5) with BTK CTOs were randomised 1:1 to DCB (N=23) or PTA (N=27). The primary effectiveness endpoint was late lumen loss (LLL) at 9 months post procedure. Safety outcomes up to 9 months included all-cause mortality, major target limb amputation, and clinically driven target lesion revascularisation (CD-TLR). Mean lesion length was 215.41±83.81 mm in the DCB group and 218.19±80.43 mm for PTA (p=0.806). The 9-month angiographic LLL was 0.892±0.774 mm for the DCB group and 1.312±0.720 mm for the PTA group (p=0.070) in a classic analysis, and 0.592±0.944 mm for DCB and 1.260±0.810 mm for PTA (p=0.017) in a subsegmental analysis. The Kaplan-Meier estimated freedom from CD-TLR up to 9 months was 91.1% for DCB and 91.8% for PTA (log-rank p=0.942). At 9 months, 1 patient died in the DCB group and 2 in the PTA group (p=1.000); there were no major target limb amputations in either arm. The 9-month subsegmental LLL was lower after treatment with the IN.PACT 014 DCB compared with PTA with no differences in safety or revascularisation events in a small complex population of patients with BTK CTOs. gov: NCT02963649.

Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study.

The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease. PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months. Mean lesion length was 14.5 ± 7.6 mm. The primary endpoint was in-stent (in-balloon) late lumen loss (LLL) by quantitative coronary angiography at 6 months post procedure. If the mean in-stent (in-balloon) LLL was less than the maximum acceptance rate of 0.50 mm at 6 months, then the study was considered successful. Mean in-stent (in-balloon) LLL was 0.05 ± 0.44 mm at 6 months post procedure. There were no deaths, myocardial infarctions, or stent (lesion) thrombosis events within 12 months. The incidence of clinically driven target-lesion revascularization was 6.0% at 12 months and clinically driven target-vessel revascularization was 10.0%. Paclitaxel DCB treatment of coronary de novo and first ISR lesions led to low LLL at 6 months and low rates of revascularization and safety events through 12 months.

One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia

BackgroundThis is the first report of the 1-year outcomes of the EVEREST-I study evaluating the safety and efficacy of the Optilume® BPH Catheter System, a prostatic paclitaxel-coated balloon catheter system, for the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH).MethodsSubjects were men >50 years old with moderate-to-severe LUTS secondary to BPH, peak urinary flow rate of 5–15 ml/s, prostatic urethra length 30–55 mm, and prostate volume 20–80 g. All were treated with the Optilume BPH Catheter System and followed at Foley removal, 2 weeks, 30 days, 3, 6, and 12 months after treatment. The primary endpoint was the proportion of subjects with ≥40% improvement in International Prostate Symptom Score (IPSS). The rate of post-procedural complications was evaluated.ResultsEighty subjects were treated at six sites in Latin America and 75 completed the 1-year follow-up. The percent of subjects with an improvement ≥40% in IPSS from baseline was 81% at 3 months and 1 year. IPSS improved from 22.3 at baseline to 7.9 at 1 year, Qmax improved from 10.9 to 18.4 ml/s, and IPSS QoL improved from 4.6 to 1.3. Post-procedural complications included common urologic events and the rate of complications was significantly impacted by device diameter.ConclusionsTreatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS. Benefits were rapid and persisted through 1 year. The initial results warrant further evaluation of this therapy as a treatment option for patients with LUTS related to BPH.

Endovascular balloon angioplasty for infrainguinal arterial occlusive disease: Efficacy analysis.

Background We present early and mid-term clinical outcomes of endovascular revascularization for femoropopliteal involvement of peripheral arterial disease. Methods A total of 128 patients (113 males, 15 females; mean age: 63.4±9.9 years; range, 32 to 87 years) who underwent percutaneous transluminal angioplasty for femoropopliteal lesions between August 2016 and April 2018 were analyzed retrospectively. Treatment with Luminor® paclitaxel-coated drug-eluting balloon catheter or bailout therapy with iVolution® self-expanding nitinol stent were performed. Overall patency rates and freedom from reintervention rates were analyzed using the Kaplan-Meier analysis. The primary patency and freedom from reintervention to target lesion rates at 12 and 24 months were evaluated. Results Technical success was achieved in 133 (93%) of the interventions with a median follow-up of 11 (range, 1 to 35) months. At 12 and 24 months, the mean overall patency rates were 85.6±3.7% and 66.8±6.7%, respectively and the mean freedom from reintervention to target lesion rates were 91.6±2.9% and 78.1±6.3%, respectively. The primary patency and freedom from reintervention to target lesion rates were significantly higher in the bailout stenting group than the drug-eluting balloon group at 12 months (97.3±2.7% vs. 94.8±6.1%, respectively, p=0.025 and 97.1±2.9% vs. 84.2±5.5%, respectively, p=0.005) and at 24 months (76.9±7.9% vs. 55.8±13.4%, respectively, p=0.025 and 85.2±7.0% vs. 70.2±13.6%, respectively, p=0.005). Conclusion Endovascular procedures including drug-eluting balloon and bailout stenting seem to be effective alternative treatment modalities for treatment of infrainguinal peripheral arterial disease and can be also used in patients with long lesions and/or total occlusion of femoropopliteal arteries.

Efficacy and safety of a magnesium stearate paclitaxel coated balloon catheter in the porcine coronary model

BackgroundLocal administration of growth-inhibiting substances such as paclitaxel or sirolimus could reduce the risk of restenosis. In the drug coated balloon (DCB) technology the coating and the applied dose seem to play a major role. The aim of the present preclinical studies was to investigate the efficacy and safety of a specific DCB with paclitaxel as active ingredient and magnesium stearate as excipient. MethodsEvaluation of the coating, drug release and transfer was done ex vivo and in vivo on peripheral arteries. A porcine coronary stent model was chosen to provoke intimal thickening. Conventional uncoated balloons were compared with paclitaxel urea and paclitaxel magnesium stearate coated balloons. QCA and histomorphometry was performed on treated vessels. Three areas of the heart were histologically examined for pathological changes. ResultsQCA and histomorphometry revealed no differences in baseline data between treatment groups. All DCB groups showed a significant reduction of angiographic and histologic parameters describing neointimal formation 4 weeks after treatment (e.g. mean angiographic late lumen loss all coated 0.31 ± 0.18 mm versus 0.91 ± 0.37 mm in the uncoated balloon group). There were no device-related animal deaths or clinical abnormalities. In spite of very slight-to-slight microscopic findings limited to small arterial vessels in downstream tissue there was no change in left ventricular ejection fraction or angiographic presentation of small side branches of treated arteries. ConclusionPaclitaxel DCB using stearate as excipient show a high efficacy in reducing neointima formation after experimental coronary intervention. No evidence of myocardial damage resulting from distal embolization was found.

Balloon-based drug coating delivery to the artery wall is dictated by coating micro-morphology and angioplasty pressure gradients

Paclitaxel coated balloon catheters (PCB) were developed as a polymer-free non-implantable alternative to drug eluting stents, delivering similar drug payloads in a matter of minutes. While PCB have shown efficacy in treating peripheral arterial disease in certain patient groups, restenosis rates remain high and there is no class effect. To help further optimize these devices, we developed a scanning electron microscopy (SEM) imaging technique and computational modeling approach that provide insights into the coating micromorphology dependence of in vivo drug transfer and retention. PCBs coated with amorphous/flaky or microneedle coatings were inflated for 60 sec in porcine femoral arteries. Animals were euthanized at 0.5, 24 and 72 h and treated arteries processed for SEM to image endoluminal coating distribution followed by paclitaxel quantification by mass spectrometry (MS). Endoluminal surfaces exhibited sparse coating patches at 0.5 h, predominantly protruding (13.71 vs 0.59%, P < 0.001), with similar micro-morphologies to nominal PCB surfaces. Microneedle coating covered a 1.5-fold endoluminal area (16.1 vs 10.7%, P = 0.0035) owing to higher proximal and distal delivery, and achieved 1.5-fold tissue concentrations by MS (1933 vs 1298 μg/g, P = 0.1745) compared to amorphous/flaky coating. Acute longitudinal coating distribution tracked computationally predicted microindentation pressure gradients (r = 0.9, P < 0.001), with superior transfer of the microneedle coatings attributed to their amplification of angioplasty contact pressures. By 24 h, paclitaxel concentration and coated tissue areas both declined by >93% even as nonprotruding coating levels were stable between 0.5 and 72 h, and 2.7-fold higher for microneedle vs flaky coating (0.64 vs 0.24%, P = 0.0195). Tissue retained paclitaxel concentrations at 24–72 h trended 1.7-fold higher post treatment with microneedle coating compared to the amorphous/flaky coating (69.9 vs 39.9 μg/g, P = 0.066). Thus, balloon based drug delivery is critically dependent on coating micromorphologies, with superior performance exhibited by micromorphologies that amplify angioplasty pressures.

Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint.

In 2013, a drug-coated balloon catheter (DCB) (SeQuent Please) for the treatment of coronary in-stent restenosis (ISR) was approved in Japan. The pre-marketing Japan domestic NP001 study demonstrated better outcomes of the DCB (n = 138) compared to plain balloon angioplasty (n = 72). After the introduction to marketing, a post-marketing surveillance (PMS) (n = 396) was conducted to evaluate the safety and efficacy of the DCB in Japanese routine clinical practice. The aim of this paper was to assess differences between the pre-marketing NP001 study and the PMS. Compared to the NP001 study, more complex lesions were treated in the PMS (type B2/C: 69.0% vs 20.4%, total occlusion: 11.2% vs 0%, p < 0.001, respectively) and target lesion was more frequently ISR related to drug-eluting stent (DES) (79.5% vs 39.4%, p < 0.001). Regarding clinical outcomes, the rate of target lesion revascularization (TLR) was higher in the PMS than in the NP001 study (TLR: 12.9% at 7months and 17.6% at 12months vs 2.8% at 6months, p = 0.001, p < 0.001, respectively). Multivariable logistic regression analysis revealed that DES-ISR was a risk factor of TLR after DCB treatment for ISR (odds ratio: 5.77, 95% CI 1.75-18.95, p = 0.004). Among representative published trials using DCB for ISR, clinical outcomes are often worse in DES-ISR trials than those in bare metal stent-ISR trials. The rates of TLR in previous DES-ISR trials are similar to that in the current PMS (TLR at 12months: 22.1% for ISAR-DESIRE 3, 15.3% for PEPCAD-DES, and 13.0% for RIBS IV). The effectiveness and safety of DCB for coronary ISR have been confirmed in the Japanese real-world survey. PMS would be useful to evaluate the safety and effectiveness of medical products throughout their total life cycles.

CRT-200.08 Six-Month Safety Evaluation of the Chocolate Touch™ Drug-Coated Balloon Catheter in the Swine Peripheral Artery Model

We evaluated the preclinical safety of a novel paclitaxel-coated balloon catheter (PCB) with a nitinol constraining structure positioned over it, designed to improve acute treatment of stenotic and occluded arteries. PCBs (TriReme Medical, Singapore) with 5.53mg PTX and (3μg/mm2, 6×80 mm) and a

A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated PTA Balloon Catheters Versus Plain Balloon PTA Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated PTA Balloon Catheters Versus Plain Balloon PTA Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

TCT-266 Long-Term Clinical Follow-Up of Small Coronary De Novo Lesions Treated With a Novel Second-Generation Paclitaxel-Coated Balloon Catheter

TCT-266 Long-Term Clinical Follow-Up of Small Coronary De Novo Lesions Treated With a Novel Second-Generation Paclitaxel-Coated Balloon Catheter

An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients

An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients

Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)

Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)