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Drug Eluting Balloon
SELUTION SLR™ DEB 014 for Peripheral Arterial Disease
N/A
Recruiting
Research Sponsored by MedAlliance, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 6, 12, 24, and 36 months
Awards & highlights
Study Summary
This trial is trying to show that a specific type of balloon called SELUTION SLR™ DEB 014 works better and is just as safe as a regular balloon in treating peripheral arterial disease in patients
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include pain at the intervention site, bleeding, infection, blood vessel damage, allergic reactions to materials used during treatment, or complications leading to further surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 6, 12, 24, and 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6, 12, 24, and 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy Endpoint
Primary Safety Endpoint
Secondary outcome measures
ABI/TBI/Toe Pressure
All-cause mortality
Amputation-free survival
+17 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SELUTION SLR™ DEB 014Experimental Treatment1 Intervention
Group II: Plain (Uncoated) Balloon Angioplasty (PTA)Active Control1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Peripheral Arterial Disease (PAD) include drug-eluting balloons (DEBs), statin therapy, antiplatelet agents, and exercise therapy. DEBs, like the SELUTION SLR™ DEB 014, release drugs such as paclitaxel to prevent restenosis by inhibiting cell proliferation and reducing inflammation in the arterial walls.
Statin therapy helps lower cholesterol levels, reducing the progression of atherosclerosis and improving overall cardiovascular health. Antiplatelet agents, such as aspirin, prevent blood clots, thereby reducing the risk of heart attacks and strokes.
Exercise therapy improves circulation and walking distance by promoting the development of collateral blood vessels. These treatments are crucial for PAD patients as they address both symptom relief and the underlying causes of the disease, improving quality of life and reducing the risk of severe complications.
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Who is running the clinical trial?
MedAlliance, LLCLead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
300 Patients Enrolled for Peripheral Arterial Disease
NAMSAOTHER
46 Previous Clinical Trials
18,456 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
606 Patients Enrolled for Peripheral Arterial Disease
M.A. Med Alliance S.A.Lead Sponsor
8 Previous Clinical Trials
5,865 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
1,127 Patients Enrolled for Peripheral Arterial Disease
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