Drug-Coated Balloon Angioplasty for Peripheral Arterial Disease
Recruiting in Palo Alto (17 mi)
+47 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 not be taking: Limus family, CYP3A4 inhibitors, CYP3A4 inducers
Disqualifiers: Stroke, MI, Renal insufficiency, others
No Placebo Group
Breakthrough Therapy
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like strong CYP3A4 inhibitors or inducers within 14 days before the procedure or plan to take them during the study. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug-coated balloon treatment for peripheral arterial disease?
Research shows that the SELUTION SLR drug-coated balloon treatment significantly reduces the narrowing of blood vessels (restenosis) in patients with femoropopliteal artery disease, with a high rate of keeping the vessels open (88.4% primary patency) and minimal adverse events over six months.
12345How is the SELUTION SLR drug different from other treatments for peripheral arterial disease?
The SELUTION SLR drug-coated balloon is unique because it uses a biodegradable polymer to create micro-reservoirs that control the release of sirolimus, a drug that was previously limited in use due to short residency time in the vessel wall. This approach differs from traditional drug-coated balloons that typically use paclitaxel and do not have this controlled release mechanism.
26789Eligibility Criteria
Adults with peripheral arterial disease in the superficial femoral or proximal popliteal artery, able to walk unassisted and expected to live more than a year. Women of childbearing age must test negative for pregnancy and use contraception post-treatment. Participants cannot have had recent surgeries or be scheduled for upcoming ones, nor can they have conditions like severe kidney issues, blood disorders, allergies to Sirolimus, or be breastfeeding.Inclusion Criteria
I am a woman able to have children, have a recent negative pregnancy test, and will use birth control for a year after treatment.
I can receive treatment for outflow disease but not with drug-eluting devices.
The blood vessel being treated is between 4mm and 7mm in diameter.
+12 more
Exclusion Criteria
Breast-feeding woman
I am allergic to Sirolimus or certain required medications for the procedure.
You have a stent in the artery that will be treated in this study.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to receive either the SELUTION SLR™ 018 DEB or plain balloon angioplasty
Immediate procedure
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of primary and secondary endpoints
12 months
Multiple visits over 12 months
Long-term Follow-up
Extended monitoring for secondary endpoints such as amputation-free survival and target lesion revascularization
2-5 years
Participant Groups
The trial is testing SELUTION SLR™ 018 DEB's safety and effectiveness against plain balloon angioplasty for treating narrowed arteries due to PAD. It focuses on patients' legs where the blood flow has been reduced because of blockages in specific arteries.
2Treatment groups
Experimental Treatment
Active Control
Group I: SELUTION SLR™ 018 DEBExperimental Treatment1 Intervention
Treatment with Selution SLR drug eluting balloon to apply long term (\>90 days) local treatment with sirolimus
Group II: Plain (Uncoated) Balloon Angioplasty (PTA)Active Control1 Intervention
Opening artery only by dilatation with an temporary inserted and inflated balloon.
SELUTION SLR™ 018 DEB is already approved in European Union, Japan, United States for the following indications:
🇪🇺 Approved in European Union as SELUTION SLR for:
- Peripheral artery disease
- Chronic limb-threatening ischemia
- Below-the-knee artery disease
🇯🇵 Approved in Japan as SELUTION SLR for:
- Superficial femoral artery disease
- Popliteal artery disease
🇺🇸 Approved in United States as SELUTION SLR for:
- Investigational Device Exemption (IDE) approval for below-the-knee indications in peripheral artery disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Bernards Medical CenterJonesboro, AR
Guardian Research Organization, LLCWinter Park, FL
Texas Cardiac and Vascular Institute San AntonioSan Antonio, TX
El Paso CardiologyEl Paso, TX
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
M.A. Med Alliance S.A.Lead Sponsor
MedAlliance, LLCLead Sponsor
Cordis CorporationIndustry Sponsor
NAMSACollaborator
References
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.
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.
Paclitaxel-coated balloon angioplasty for lower extremity revascularization: a new way to fight in-stent restenosis. [2016]In the last years the development of new techniques and technologies for the endovascular treatment of peripheral arterial occlusive disease has allowed to treat a vast array of lesions with high technical success and low complications. Despite these advances, restenosis, and in particular in-stent restenosis, is a problem that significantly affects middle and long-term results and remains to be solved. Drug-eluting balloons (DEB) have shown good results in the treatment of coronary in-stent restenosis in experimental and clinical trials, but only few experimental and clinical trials focus on the peripheral district. This review summarizes the available experimental and clinical data in support of DEB in the treatment of ISR in the peripheral district. Larger clinical trials focused on paclitaxel-coated balloon in the treatment of ISR in the peripheral arteries will be necessary to provide definitive evidence of clinical benefit.
Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. [2022]Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease.
Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial. [2020]Although paclitaxel drug-coated balloon (DCB) angioplasty is an established endovascular treatment for peripheral artery disease, restenosis remains a major concern. Thus, we compared a novel paclitaxel-coated DCB with nano-coating technology with uncoated plain old balloon angioplasty (POBA).
Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial. [2020]We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions.
Opportunities and limitations of drug-coated balloons in interventional therapies. [2021]Drug-coated balloons (DCB) represent a novel clinical treatment modality for coronary and peripheral artery disease. Advantages over standard angioplasty and stent technologies including homogeneous drug delivery to the vessel wall, immediate drug release without the use of a polymer, the option of using balloon catheters alone or in combination with a bare metal stent, no foreign object that remains in the body, the potential of reducing antiplatelet therapy, and lower restenosis rates in some indications. As with drug-eluting stents (DES), one cannot assume a class effect for DCB. So far, data from randomized clinical trials identify the treatment of coronary in-stent restenosis (ISR) and of de novo and restenotic lesions in peripheral artery disease as viable options. Furthermore, treatment of de novo lesions in small coronary vessels, bifurcation lesions, long lesions, pediatric interventions, and cerebrovascular applications are potential beneficial indications. In the coronary application, a strategy of DCB angioplasty with provisional spot-stenting in the case of severe dissections may become a better alternative in long and complex lesions, bifurcations, or in patients with contraindications for DES.