Sirolimus Coated Balloon Research Articles

Sirolimus Coated Balloon For Femoropopliteal And Below The Knee Disease: Xtosi Trial 24 Month RESULTS

Sirolimus coated balloon (SCB) is a potential treatment option for peripheral arterial occlusive disease (PAOD). However, clinical data for this novel treatment for PAOD are lacking. We present the 24 months RESULTS of the first-in-human study of MagicTouch PTA SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK).

Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon.

Limus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein we evaluated its performance in a real-world patient cohort with complex coronary artery lesions. Patients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization. From September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a "DCB only" strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0-12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed. In complex coronary lesions, a "DCB only" strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.

Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions

BackgroundNon stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. MethodsThis was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. ResultsA total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. ConclusionThe novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.

Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial.

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications. TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings. The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.

Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. URL: https://www. gov; Unique identifier: NCT02996318, NCT03242096.

TCT-139 Long-Term Clinical Outcomes of a Novel Sirolimus-Coated Balloon in Coronary Intervention: Data From a Real-World Population

TCT-139 Long-Term Clinical Outcomes of a Novel Sirolimus-Coated Balloon in Coronary Intervention: Data From a Real-World Population

TCT-224 MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: XTOSI Trial 24 Month Results

TCT-224 MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: XTOSI Trial 24 Month Results

TCT-136 Use of Sirolimus-Coated Balloon in De Novo Small-Vessel Coronary Lesions in Acute Coronary Syndrome: Long-Term Follow-Up From a Single-Center Registry

TCT-136 Use of Sirolimus-Coated Balloon in De Novo Small-Vessel Coronary Lesions in Acute Coronary Syndrome: Long-Term Follow-Up From a Single-Center Registry

TCT-138 Clinical Outcomes Following Use of Sirolimus-Coated Balloon in a Side Branch During Provisional Stent Technique in True Bifurcations

TCT-138 Clinical Outcomes Following Use of Sirolimus-Coated Balloon in a Side Branch During Provisional Stent Technique in True Bifurcations

Sirolimus-Coated Balloon Angioplasty of Infra-popliteal Lesions for the Treatment of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized Controlled LIMES Study

PurposeEvidence on efficacy and long-term safety of paclitaxel-coated devices is still conflicting. Therefore, this study aims to assess whether sirolimus-coated balloon angioplasty is safe and effective for the treatment of infra-popliteal occlusions in patients with chronic limb-threatening ischemia (CLTI).Study designThe randomized controlled, single-blinded, multicentre, investigator-initiated study aims to enrol 230 participants with CLTI and infra-popliteal occlusions at up to 25 centres. Patients will be randomized in a 1:1 ratio to either sirolimus-coated balloon angioplasty or to plain old balloon angioplasty (POBA). Bailout stenting in case of flow-limiting dissection or ≥ 50% residual diameter stenosis is permitted.Outcome measuresPrimary outcome is the Kaplan–Meier estimate of primary patency at 6 months, defined as the absence of target lesion occlusion with restoration of in-line flow to the ankle. Key secondary outcome is non-inferiority in the proportionate occurrence of major adverse limb events and perioperative all-cause death at 30 days. Overall, participants will be followed for 36 months to assess further secondary efficacy and safety outcomes.Assumed gain of knowledgeIf sirolimus-coated balloon angioplasty turns out to be superior to uncoated-balloon angioplasty regarding patency of infra-popliteal lesions without safety signals, it could become a welcome treatment option for patients with CLTI.Trial Registration ClinicalTrial.gov Identifier: NCT04772300, German Clinical Trials Register: DRKS00024629.Level of Evidence Level 2a, randomized controlled trial.

‘Leave Nothing Behind’ Strategy in Coronary and Peripheral Artery Disease: An Insight into Sirolimus-Coated Balloons

The long-term complications associated with stent implantation for the treatment of coronary and peripheral artery disease have prompted a search for more conservative treatments, and a ‘leave nothing behind’ strategy. Drug-coated balloons are an attractive alternative that combine the advantages of balloon angioplasty with inhibition of neointimal proliferation and restenosis. Paclitaxel has so far been the drug of choice in balloon coating, given its high lipophilicity and local tissue retention. Still, its use is limited by a narrow therapeutic window and safety concerns. Sirolimus-coated balloons entered the drug-coated balloon arena late because of the need to use specific technologies to overcome pharmacokinetic limitations. Their use was initially tested in in-stent restenosis and small-calibre native vessels, demonstrating results that overlapped with those obtained with paclitaxel-coated balloons in terms of efficacy. New indications for sirolimus-coated balloon angioplasty are emerging, such as acute coronary syndromes, coronary bifurcations, peripheral and coronary medium- to large-calibre native vessels, critical limb ischaemia, vasculogenic erectile dysfunction, and dysfunctional arteriovenous fistulas. Data in these areas are still limited to small, non-randomised studies, showing encouraging results.

Sirolimus-coated balloon angioplasty in maintaining the patency of thrombosed arteriovenous graft: 1-year results of a prospective study.

A prospective, pilot study was designed to test the feasibility of using sirolimus-coated balloon (SCB) to treat graft vein junction of thrombosed arteriovenous graft (AVG) following successful pharmacomechanical thrombectomy. The present report provides the 1-year results of this study. This is a 1-year follow-up of a single, prospective, single-arm study that was conducted from 2018 to 2019 in 20 patients who presented to a tertiary institution with thrombosed AVG. The recruited patients received SCB angioplasty at the graft-vein junction following successful endovascular thrombectomy of a thrombosed AVG. One year after recruitment, there were three deaths, one AVG revision, and one AVG explantation among the participants recruited. The outcomes of 15 subjects at 1-year following the index procedure obtained from electronic medical records were re-examined. The 1-year access circuit primary patency rate was 40%, while assisted primary and secondary patency rates were 46.7% and 73.3%, respectively. A total of 16 interventions (4 angioplasties, 12 thrombectomies) were performed in 9 patients over the 12 months. Four AVGs were abandoned. The median number of interventions per patient was 1 (0-3) per year. Using Kaplan-Meier analysis, the mean estimated post-intervention access circuit primary patency was 230 (95% CI: 162-300) days, while access circuit assisted primary patency was 253 (95% CI: 187-320) days, and access circuit secondary patency was 292 (95% CI: 230-356) days. Sub-group analysis did not show a significant difference in the mean estimated primary patency between AVG with de novo and recurrent stenosis (245 days, 95% CI: 151-339 vs 210 days, 95% CI: 113-307; p = 0.29). SCB may help sustain the patency of thrombosed AVG following successful thrombectomy.

Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the \u201cSirPAD\u201d randomized controlled trial

BackgroundPeripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for “hard” clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability.MethodsIn this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective “hard” outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes.DiscussionBy focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative (“all-comer”) population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected.Trial registrationClinicalTrials.govNCT04238546

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).

TCTAP A-043 Long-Term Safety and Efficacy Outcomes After Treatment of Coronary Artery Lesions Using Sirolimus Coated Balloons: Insights From Real-World All-Comer Patients

TCTAP A-043 Long-Term Safety and Efficacy Outcomes After Treatment of Coronary Artery Lesions Using Sirolimus Coated Balloons: Insights From Real-World All-Comer Patients

Slow-flow phenomena following lower limb paclitaxel- and sirolimus-coated balloon angioplasty in the setting of chronic limb threatening ischaemia—a case series

The Achilles heel of plain old balloon angioplasty (POBA) is neointimal hyperplasia (NIH) and restenosis, caused from the barotrauma of ballooning. Drug-coated balloons using a paclitaxel-based platform (PCB) have been shown to retard the restenotic process, using the anti-proliferative effects of paclitaxel, and give longer vessel patency. This is important in the setting of chronic limb threatening ischemia (CLTI) and for the protracted wound healing process in these frail patients. However, during PCB application, more than 50% of the drug is lost downstream, a phenomenon termed particulate embolization. This is thought to account for the slow- or no-flow phenomenon encountered after PCB use. Recent data suggest that slow-flow phenomenon was associated with a lower target lesion revascularisation rate and worse amputation free survival (AFS). The use of sirolimus coated balloons (SCB) to impede the NIH cascade has been less well studied but recent data suggested excellent short-term efficacy and found no slow flow phenomenon with their use in the tibial arteries in CLTI patients. Aim of this case series is to highlight the difference in flow phenomena using PCB and SCB elution in the setting of CLTI. We evaluated the use of parametric colour coding and time attenuation curves (TAC) as a quantitative measure of blood flow. SCB may have an advantage over PCB use in the peripheral vasculature because of a reduced incidence of slow flow phenomenon following drug elution.

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months

Introduction: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). Material and Methods: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. Results: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001) and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%). Conclusions: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.

SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial

BackgroundPercutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied.Methods/designThis is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical.DiscussionThis study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients.Trial registrationClinicalTrials.govNCT04409912. Registered on 1 June 2020

Paclitexel versus sirolimus-coated balloon in the treatment of coronary instent restenosis.

Few studies compared paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB) in the treatment of drug-eluting stent (DES) instent restenosis (ISR). Between November 5, 2009, and October 14, 2020, in our center 212 patients with first DES-ISR were treated with PCB (Restore®; Cardionovum GmbH, Bonn, Germany), whereas 230 patients were treated with SCB (Devoir®; MINVASYS SAS, Gennevilliers, France). Following a propensity matching, 186 patients were included into PCB group (PCB group), and in the SCB group (SCB group). The primary purpose of the study was the 1-year target lesion failure (TLF) rate, including cardiac death, target vessel-related myocardial infarction, and repeated target lesion or target vessel revascularization. Procedural success occurred in all cases. Fully optimal predilation (that is, balloon-to-stent ratio >0.91, time of DCB inflation >60 sec, and residual percent diameter stenosis after lesion preparation <20%) was observed more often in the SCB group (126 [68%] patients versus 106 [57%] patients; P=0.042). One-year TLF occurred in 29 (15.5%) patients in the SCB group and in 32 (17%) patients in the PCB group (OR=1.12 [0.65-1.95]; P=0.78). By logistic Cox regression analysis fully optimal predilation (OR=0.06; 95% CI: 0.01-0.21; P<0.001) but not DCB type (OR=0.74; 95% CI: 0.41-1.31; P=0.29) was independent predictor of 1-year TLF. The current study suggests that 1-year TLF is not statistically and clinically different in patients with DES ISR treated with a PCB and a SCB.

TCT-447 Three-Year Follow-Up After Treatment of Coronary Artery Lesions Using Sirolimus-Coated Balloons: Insights From Real-World All-Comer Patients

TCT-447 Three-Year Follow-Up After Treatment of Coronary Artery Lesions Using Sirolimus-Coated Balloons: Insights From Real-World All-Comer Patients