Sirolimus drug coated balloon for treating artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Khoo Teck Puat Hospital
  Singapore, Singapore Recruiting
• National University Hospital
  Singapore, Singapore 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

Study contacts

• Principal investigator: Edward Choke — Sengkang General Hospital
• Study coordinator: Edward Choke
• Email: tcchoke@hotmail.com
• Phone: +65 69302164

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.