SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease

Launched by CONCEPT MEDICAL INC. · Aug 10, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with below-the-knee arterial disease, a condition that affects blood flow to the legs. The trial compares a special balloon coated with a medication called sirolimus to the standard treatment, which is a procedure that opens up blocked arteries. The goal is to see if the sirolimus-coated balloon can help improve blood flow better than the usual method.

To participate in the trial, you need to be at least 21 years old and have specific types of blockages in your leg arteries that are causing symptoms. Participants will undergo procedures to treat their arterial disease and will be closely monitored to see how well the treatment works. It's important to know that some people may not qualify for the study, such as those with certain serious health conditions or who are currently pregnant. If you meet the criteria and decide to join, you’ll be part of a research effort that aims to improve treatment options for people with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 21 years or minimum age
• • 2. Rutherford class 4 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 proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery, posterior tibial artery and peroneal artery
• • 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. Target vessel has angiographically documented run off to the foot after treatment (ie. without significant stenosis)
• 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. Target vessel has lesions extending beyond the ankle joint
• • 13. Failure to obtain \<30% residual stenosis in a pre-existing lesion
• • 14. Lesions requiring retrograde access (SAFARI)
• • 15. Highly calcified lesions (Contiguous calcification on both sides of the lesion)
• • 16. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)