What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include drug-eluting balloons (DEBs), such as the SELUTION SLR™ DEB 014, which release drugs to prevent restenosis. Known side effects of DEBs can include local complications such as vessel dissection, perforation, and restenosis. Systemic side effects may include allergic reactions to the drug coating. Other common PAD treatments, such as supervised exercise programs and pharmacologic therapies like cilostazol, may cause headaches, diarrhea, and palpitations. Statin therapy, often used to manage PAD, can lead to muscle pain and liver enzyme abnormalities. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several drug-eluting technologies for the treatment of Peripheral Arterial Disease (PAD), aimed at preventing restenosis. These include drug-eluting stents (DES) and drug-coated balloons (DCB) that release antiproliferative drugs such as paclitaxel. These devices have been shown to improve the longevity of interventions by reducing the rate of restenosis in the treated arteries. The SELUTION SLR™ DEB 014, currently under trial, is a drug-eluting balloon designed to release a drug to prevent restenosis, similar to previously approved paclitaxel-coated balloons and stents.

What other types of research exist?

Promising alternatives to SELUTION SLR™ DEB 014 for PAD patients include: 1) PCSK9 inhibitors like evolocumab and alirocumab, which have shown efficacy in reducing major adverse limb events. 2) GLP1 receptor agonists such as liraglutide and semaglutide, which have demonstrated benefits in reducing cardiovascular events and amputations in PAD patients. 3) Advanced revascularization techniques, including drug-coated balloons (DCBs) and bioresorbable vascular scaffolds (BVS), which are being evaluated for their potential to improve long-term outcomes in PAD.

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Drug Eluting Balloon

SELUTION SLR™ 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

No Placebo-Only Group

Summary

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6, 12, 24, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Endpoint

Primary Safety Endpoint

Secondary study objectives

ABI/TBI/Toe Pressure

Amputation-free survival

CD-TLR

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

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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.