SELUTION SLR™ for Peripheral Arterial Disease
Recruiting in Palo Alto (17 mi)
+39 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: MedAlliance, LLC
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a special balloon called SELUTION SLR™ DEB 014 for patients with severe leg artery blockages. The balloon helps open the artery and releases medicine to prevent it from getting blocked again.
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that subjects with contraindications to antiplatelet therapy are excluded, and those with hypersensitivity to certain agents required for the procedure must be adequately pre-treated. It's best to discuss your current medications with the trial team to ensure compatibility.
What safety data is available for SELUTION SLR™ in treating Peripheral Arterial Disease?The SELUTION SLR™ drug-eluting balloon has been evaluated for safety and efficacy in treating femoropopliteal lesions. In a first-in-human trial with 50 subjects, the SELUTION SLR showed a median angiographic late lumen loss of 0.19 mm at 6 months, significantly lower than the 1.04 mm objective performance criterion for uncoated balloon angioplasty. The primary patency rate was 88.4%, and freedom from angiographic binary restenosis was 91.2%. There was a significant improvement in clinical outcomes, with only one case (2%) of clinically-driven target lesion revascularization and no other major adverse events reported. These results suggest that the SELUTION SLR is effective and safe in inhibiting restenosis and improving outcomes in patients with symptomatic femoropopliteal disease.23456
Is the SELUTION SLR™ DEB 014 treatment promising for Peripheral Arterial Disease?Yes, the SELUTION SLR™ DEB 014 treatment is promising for Peripheral Arterial Disease. It effectively reduces the narrowing of blood vessels and improves blood flow in patients with leg artery issues. In a study, it showed better results than traditional methods, with a high rate of keeping the arteries open and very few complications.23456
What data supports the idea that SELUTION SLR™ for Peripheral Arterial Disease is an effective treatment?The available research shows that the SELUTION SLR™ treatment is effective for Peripheral Arterial Disease. In a study with 50 participants, the treatment led to a significant improvement in blood flow in the affected arteries. After six months, the narrowing of the arteries was much less compared to the standard treatment, with a median reduction of 0.19 mm in artery narrowing, which is better than the 1.04 mm expected with the usual treatment. Additionally, 88.4% of the treated arteries remained open, and 91.2% did not show significant narrowing again. These results suggest that SELUTION SLR™ is a safe and effective option for improving artery health in patients with this condition.12346
Eligibility Criteria
This trial is for adults with chronic limb-threatening ischemia in the lower limbs, who have a life expectancy of at least one year and can follow study procedures. They must not be pregnant or breastfeeding and agree to use contraception if applicable. The disease should be classified as Rutherford category 4-6, affecting arteries below the knee but above the ankle without severe blockages elsewhere.Participant Groups
The SELUTION SLR™ DEB 014 drug-coated balloon is being tested against plain balloon angioplasty for treating peripheral arterial disease in arteries below the knee. The goal is to see if it's more effective and just as safe.
2Treatment groups
Experimental Treatment
Active Control
Group I: SELUTION SLR™ DEB 014Experimental Treatment1 Intervention
Group II: Plain (Uncoated) Balloon Angioplasty (PTA)Active Control1 Intervention
SELUTION SLR™ DEB 014 is already approved in European Union, United States, Japan for the following indications:
🇪🇺 Approved in European Union as SELUTION SLR for:
- Peripheral artery disease
- Coronary artery disease
- Below-the-knee (BTK) indications
- Superficial femoral artery (SFA) occlusive disease
- Coronary in-stent restenosis (ISR)
🇺🇸 Approved in United States as SELUTION SLR for:
- Investigational for coronary de novo lesions, below-the-knee (BTK) indications, superficial femoral artery (SFA) occlusive disease, and coronary in-stent restenosis (ISR)
🇯🇵 Approved in Japan as SELUTION SLR for:
- Superficial femoral artery (SFA) and popliteal artery (PA) lesions
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Massachusetts Medical CenterWorcester, MA
Sentara Norfolk General HospitalNorfolk, VA
Miriam HospitalProvidence, RI
Texas Cardiac and Vascular Institute San AntonioSan Antonio, TX
More Trial Locations
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Who is running the clinical trial?
MedAlliance, LLCLead Sponsor
M.A. Med Alliance S.A.Lead Sponsor
NAMSACollaborator
Cordis CorporationIndustry Sponsor
References
Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease: A meta-analysis of randomized trials. [2022]Drug-eluting balloon (DEB) and standard percutaneous transluminal angioplasty (PTA) are commonly used endovascular therapeutic procedures for the revascularization of infrapopliteal arterial occlusive disease. However, which procedure is more beneficial for patients is unknown.
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.
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.
Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results. [2023]Label="BACKGROUND" NlmCategory="UNASSIGNED">The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. MedAlliance SA, Nyon, Switzerland) for improving the patency of failing arterio-venous fistulas (AVF) in hemodialysis patients. We also present herein a pre-clinical pharmacokinetic and safety evaluation of Selution™ to justify its first use in hemodialysis patients for endovascular access salvage.
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.
Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. [2023]Label="BACKGROUND">Drug eluting stents (DES) are associated with a 2% to 4% annual rate of target lesion failure through 5-to-10-year follow-up. The presence of a metallic protheses is a trigger for neo-atherosclerosis and very late stent thrombosis. A "leave nothing behind" strategy using Drug Coated Balloons has been suggested; however, paclitaxel coated balloons are only recommended in selected indications. Recently a novel sirolimus eluting balloon, the SELUTION SLR TM 014 PTCA balloon (SEB) (M.A. MedAlliance SA, Nyon, Switzerland) has been developed.