Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease

Launched by CONCEPT MEDICAL INC. · Aug 10, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special type of balloon coated with a medication called sirolimus, compared to a standard balloon, for treating problems in the superficial and popliteal arteries, which are important blood vessels in the legs. The goal is to see if the sirolimus-coated balloon can help improve blood flow better than the standard treatment for people with peripheral artery disease, a condition where arteries become narrow or blocked.

To be eligible to participate in this trial, you must be at least 21 years old and have specific types of blockages in your leg arteries. The trial is open to all genders and is currently recruiting participants. If you join, you can expect to receive either the sirolimus-coated balloon treatment or the standard balloon treatment, and you will be closely monitored throughout the study. It's important to note that certain health conditions, like severe bleeding disorders or pregnancy, may prevent you from participating in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 21 years or minimum age
• • 2. Rutherford class 3 to 6 in the target limb
• • Intraoperative Inclusion Criteria
• • 3. Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2
• • 4. Inflow free from flow limiting lesions (\<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\>50% stenosis) can be included if lesion had been treated successfully (\<30% residual stenosis) before or during the index procedure.
• • 5. At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.
• Exclusion Criteria:
• • 1. Comorbid conditions limiting life expectancy ≤ 1 year
• • 2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
• • 3. Subject is pregnant or planning to become pregnant during the course of the study
• • 4. Heel gangrene
• • 5. Prior bypass surgery of target vessel
• • 6. Planned amputation of the target limb
• • 7. Previously implanted stent in the target lesion
• • 8. Vulnerable or protected adults
• • 9. Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin
• • 10. Known allergy to sirolimus
• • Intraoperative Exclusion Criteria
• • 11. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations)
• • 12. Failure to obtain \<30% residual stenosis in a pre-existing lesion
• • 13. Highly calcific lesions
• • 14. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
• • 15. Lesions requiring retrograde access (SAFARI)