Sirolimus drug coated balloon treatment for below the knee arterial 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 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.

Why it matters

Who can join: the full rules

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 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.