Sirolimus drug coated balloon for treating artery disease

Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease

This study is testing if a special balloon coated with sirolimus can help people with peripheral artery disease by reducing the chance of their arteries narrowing again compared to regular balloons.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 279 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Concept Medical Inc. (industry)
• Locations: 20 sites (Singapore and 19 other locations)
• Trial ID: NCT04511234 on ClinicalTrials.gov

What this trial studies

This study conducts a randomized, double-blind trial comparing sirolimus drug coated balloons to standard balloons for treating superficial and popliteal artery disease in patients with peripheral artery disease (PAD). The trial aims to evaluate the effectiveness of sirolimus in delivering anti-proliferative drugs directly to arterial lesions, potentially reducing the risk of restenosis. Given the concerns surrounding paclitaxel-based drug coated balloons, this study seeks to explore sirolimus as a safer alternative with promising preliminary results. Participants will be monitored for procedural success and patency over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with Rutherford class 3 to 6 PAD affecting the femoropopliteal arteries.

Not a fit: Patients with comorbid conditions limiting life expectancy to one year or less may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with peripheral artery disease.

How similar studies have performed: Previous studies have shown success with drug coated balloons, but this specific approach using sirolimus is novel and untested in this context.

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)

Where this trial is running

Singapore and 19 other locations

• Khoo Teck Puat Hospital — Singapore, Singapore (RECRUITING)
• National University Hospital — Singapore, Singapore (RECRUITING)
• Ng Teng Fong General Hospital — Singapore, Singapore (NOT_YET_RECRUITING)
• Sengkang General Hospital — Singapore, Singapore (RECRUITING)
• Singapore General Hospital — Singapore, Singapore (RECRUITING)
• Tan Tock Seng Hospital — Singapore, Singapore (RECRUITING)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)
• Kaoshiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)
• Far Eastern Memorial Hospital — New Taipei City, Taiwan (RECRUITING)
• Taipei Tzuchi Hospital — New Taipei City, Taiwan (RECRUITING)
• China Medical University Hospital — Taichung, Taiwan (NOT_YET_RECRUITING)
• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
• Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan (RECRUITING)
• Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan (RECRUITING)
• Phramongkutklao Hospital — Bangkok, Thailand (RECRUITING)
• Rajavithi Hospital — Bangkok, Thailand (RECRUITING)
• Ramathibodi Hospital — Bangkok, Thailand (NOT_YET_RECRUITING)
• Siriraj Hospital — Bangkok, Thailand (RECRUITING)
• Vajira Hospital — Bangkok, Thailand (RECRUITING)
• Thammasat University Hospital — Pathum Thani, Thailand (RECRUITING)

Study contacts

• Principal investigator: Edward Choke — Sengkang General Hospital
• Study coordinator: Edward Choke

Conditions: Peripheral Artery Disease, Atherosclerosis, Arterial Disease, PAD, DCB, PTA, Sirolimus