SELUTION4BTK Trial for Peripheral Arterial Disease
This study is testing a new device called SELUTION SLR™ DEB 014 for people with peripheral arterial disease (PAD) in their lower leg arteries, specifically chronic limb-threatening ischemia (CLTI). This device is a special balloon that releases medicine to open up narrowed arteries. Researchers want to see if SELUTION SLR™ DEB 014 works better than a standard, uncoated balloon angioplasty (a procedure using a plain balloon to open arteries) and if it's just as safe. You might be able to join if you are 18 or older, have a life expectancy of at least one year, and have documented CLTI in your leg for more than two weeks. The study aims to enroll 376 participants. The current status of the study is unclear.
- Study design
- This is an interventional study comparing two different devices. It plans to enroll 376 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be checked for 30 days, and the effectiveness of the treatment will be measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SELUTION4BTK Trial
At a glance
Conditions
Where it's being run
48 sites across 29 statesWho to contact
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What this trial measures
- Primary Efficacy Endpoint6 months
Hierarchical composite efficacy endpoint determined by pair-wise comparisons among all subjects (Win Ratio method) according to the following pre-specified hierarchy of adverse outcomes: * Major (above-the-ankle) amputation * CD-TLR * Target lesion occlusion by angiography (if angiography is not available, the decision will be made on a secondary modality, in order of preference: computed tomography angiogram \[CTA\], magnetic resonance angiography \[MRA\] or DUS) * Transverse View Area Loss (TVAL%) by angiography.
- Primary Safety Endpoint30 days
Freedom from the composite of MALE and all-cause perioperative death (POD). MALE is defined as major (above-the-ankle) amputation or major reintervention (new bypass graft, jump/ interposition graft revision, thrombectomy/thrombolysis) of the index limb.