SELUTION SLR DCB vs. "-limus" DES for Coronary Artery Disease
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.A. Med Alliance S.A.
Must be taking: Dual antiplatelet therapy
Must not be taking: Strong CYP3A4 inhibitors, inducers
Disqualifiers: Heart failure, STEMI, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.
The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.
Will I have to stop taking my current medications?
The trial requires that participants can tolerate dual antiplatelet therapy with aspirin and another medication like Clopidogrel, Prasugrel, or Ticagrelor. If you are taking strong CYP3A4 inhibitors or inducers, you may need to stop them 14 days before the procedure and during the study period. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the study team.
What data supports the effectiveness of the SELUTION SLR treatment for coronary artery disease?
The Selution SLR drug-coated balloon (DCB) is a new treatment that releases a drug called sirolimus, which helps prevent the artery from narrowing again after a procedure. It has shown promise in treating complex coronary artery lesions, suggesting it could be effective for coronary artery disease.
12345Is the SELUTION SLR DCB and -limus DES safe for humans?
Research shows that various -limus drug-eluting stents, including sirolimus and zotarolimus types, have been studied for safety, with some concerns about issues like in-stent restenosis (narrowing of the stent) and very late stent thrombosis (blood clot formation). The SELUTION SLR drug-coated balloon has been evaluated for safety in treating certain artery diseases, indicating it is generally safe for human use.
12367What makes the SELUTION SLR DCB drug unique for treating coronary artery disease?
The SELUTION SLR drug-coated balloon (DCB) is unique because it uses a biodegradable polymer to create micro-reservoirs that release sirolimus, an antiproliferative drug, in a controlled manner. This approach aims to reduce issues like in-stent restenosis and very late stent thrombosis, which are concerns with traditional drug-eluting stents.
23689Eligibility Criteria
This trial is for adults with small vessel coronary artery disease who need PCI and can tolerate dual antiplatelet therapy. They should not be pregnant, planning surgery within 30 days, or have severe heart failure. Participants must be willing to follow study procedures and use contraception if applicable.Inclusion Criteria
Subject has life expectancy > 1 year in the opinion of the investigator
My target lesion is highly likely (>70%) to respond well to specific pre-treatment and DEB.
Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm [by visual assessment]
+13 more
Exclusion Criteria
Subjects who meet any of the following clinical criteria will be excluded from the trial:
I am scheduled for treatment on a lesion near the beginning of my aorta.
I am allergic to Sirolimus or similar medications.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive treatment with either the SELUTION SLR 014 PTCA DEB or a contemporary DES for de novo coronary lesions in small vessels
Up to 7 days
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including angiography at 12 months for the angiographic substudy
12 months
Multiple visits (in-person and virtual)
Long-term Follow-up
Participants are monitored for long-term safety and effectiveness outcomes
5 years
Participant Groups
The SELUTION SLR DCB device is being tested against FDA-approved '-limus' DES in treating de novo lesions in small coronary vessels. This randomized controlled trial aims to enroll up to 910 subjects across multiple countries.
2Treatment groups
Experimental Treatment
Active Control
Group I: SELUTION SLR 014 PTCA DEBExperimental Treatment1 Intervention
SELUTION Sustained Limus Release (SLR) 014 Percutaneous Transluminal Coronary Angioplasty (PTCA) Drug Eluting Balloon (DEB)
The SELUTION SLR 014 PTCA DEB is a minimally invasive, single use and sterile Sirolimus coated PTCA balloon catheter.
The SELUTION SLR 014 PTCA DEB is available with balloon diameters from 2.0 to 3.0 mm and lengths of 15 to 40 mm for the purpose of the De Novo IDE trial
Group II: Control TreatmentActive Control1 Intervention
any FDA approved "limus-based" Drug Eluting Stent, as per standard institutional practice
-limus DES is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Limus drug-eluting stent for:
- Coronary artery disease
- Peripheral artery disease
🇺🇸 Approved in United States as Limus drug-eluting stent for:
- Coronary artery disease
- Peripheral artery disease
🇨🇦 Approved in Canada as Limus drug-eluting stent for:
- Coronary artery disease
- Peripheral artery disease
🇯🇵 Approved in Japan as Limus drug-eluting stent for:
- Coronary artery disease
- Peripheral artery disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
HCA Los RoblesThousand Oaks, CA
Harbor UCLATorrance, CA
HCA Florida JFKAtlantis, FL
University of Florida, JacksonvilleJacksonville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
M.A. Med Alliance S.A.Lead Sponsor
NAMSACollaborator
Cordis CorporationIndustry Sponsor
References
Two zotarolimus-eluting stent generations: a meta-analysis of 12 randomised trials versus other limus-eluting stents and an adjusted indirect comparison. [2016]To evaluate efficacy and safety of two zotarolimus-eluting stent generations versus other limus-eluting stents (LES), and to compare Resolute zotarolimus-eluting stents (R-ZES) with Endeavor zotarolimus-eluting stents (E-ZES).
2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based Cypher and Endeavor [corrected] drug-eluting stents. [2022]In the ISAR-TEST-2 (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents) randomized trial, a new-generation sirolimus- and probucol-eluting stent (Dual-DES) demonstrated a 12-month efficacy that was comparable to sirolimus-eluting stents (SES) (Cypher, Cordis Corp., Warren, New Jersey) and superior to zotarolimus-eluting stents (ZES) (Endeavor, Medtronic CardioVascular, Santa Rosa, California). The aim of the current study was to investigate the comparative clinical and angiographic effectiveness of SES, Dual-DES, and ZES between 1 and 2 years.
Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon. [2023]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.
Coronary Stents in Diabetic Patients: State of the Knowledge. [2018]This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population.
World's First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study. [2021]The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI.
Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry. [2023]The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease.
Safety and efficacy of everolimus-eluting stent versus zotarolimus-eluting stent: A meta-analysis of randomized controlled clinical trials and observational studies. [2015]The safety and efficacy of everolimus-eluting stent (EES) versus zotarolimus-eluting stent (ZES) are controversial both in randomized controlled clinical trials (RCTs) and observational studies. The aim of this study was to assess the safety and efficacy of EES versus ZES.
The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions. [2021]Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel. Use of limus drugs was limited by a short residency time in the vessel wall. Besides the drug, the SELUTION SLR™ drug-eluting balloon system consists of a coating formulation of four excipients. The first excipient is a biodegradable polymer (poly(lactic-co-glycolic acid)) that is intermixed with the sirolimus to form micro-reservoirs and regulates drug release via matrix degradation. This review summarizes the existing pre-clinical and clinical literature on treatment of femoropopliteal artery lesions with the SELUTION SLR DCB.
Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions. [2020]Purpose: To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Materials and Methods: Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 or 3) were enrolled at 4 German centers for the SELUTION SLR first-in-human trial (ClinicalTrials.gov NCT02941224). The SELUTION SLR utilizes micro-reservoirs (biodegradable polymer spheres containing sirolimus) embedded within an amphipathic membrane coated onto an angioplasty balloon. The biodegradable reservoirs are transferred to the target vessel lumen during brief balloon inflation. The primary trial objective was comparison of angiographic late lumen loss at 6 months against an objective performance criterion (OPC) value of 1.04 mm for uncoated balloon angioplasty. Secondary endpoints included device, procedural, and clinical success; clinical and imaging assessments of primary patency and restenosis; functional assessments including Rutherford category and ankle-brachial index (ABI); and major adverse events [composite of cardiovascular mortality, index limb amputation, target limb thrombosis, and clinically-driven target lesion revascularization (CD-TLR)]. Results: At 6 months, median angiographic late lumen loss following SELUTION SLR treatment was 0.19 mm (range -1.16 to 3.07). Mean angiographic late lumen loss (n=34) was 0.29±0.84 mm (95% CI -0.01 to 0.58), significantly lower than the 1.04-mm OPC value (p<0.001). The rate of primary patency by duplex ultrasound was 88.4%, and freedom from angiographic binary restenosis was 91.2%. Through 6 months, there was significant improvement over baseline in Rutherford categories (p<0.001) and in ABI measurements (p<0.001). A single case (2%) of CD-TLR occurred at 5 months. There were no other major adverse events. Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with symptomatic femoropopliteal disease.