Sirolimus drug coated balloon treatment for below the knee arterial disease

FUTURE BTK: Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Below The Knee Arterial Disease

This study is testing if a new sirolimus drug-coated balloon can help people with peripheral artery disease have better results than the standard treatment for below the knee arterial problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 219 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Concept Medical Inc. (Industry-sponsored)
• Locations: 20 sites (Singapore and 19 other locations)
• Trial ID: NCT04511247 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a sirolimus drug coated balloon compared to standard percutaneous transluminal angioplasty for treating below the knee arterial disease, specifically targeting patients with peripheral artery disease. It is a randomized, double-blind, multicenter trial that aims to deliver localized anti-proliferative treatment to arterial lesions, potentially improving patient outcomes. The study is motivated by the need for safer alternatives to existing drug coated balloons, particularly in light of recent concerns regarding the safety of paclitaxel-based treatments. The trial will assess the safety and efficacy of sirolimus in preventing restenosis in affected arteries.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 and older with Rutherford class 4 to 6 peripheral artery disease affecting below the knee arteries.

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

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for patients suffering from below the knee arterial disease.

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

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)

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 of Legs; PAD; DCB; PTA; Sirolimus