NCT06182397 Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
| NCT ID | NCT06182397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Concept Medical Inc. |
| Condition | Arterial Disease of Legs |
| Study Type | INTERVENTIONAL |
| Enrollment | 368 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 368 participants in total. It began in 2025-01-16 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited. The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease. Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either: 1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \> 21 years OR adulthood minimum age (depending on the US state regulations) 2. Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population. 3. Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative Inclusion Criteria: 4. 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 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. 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 unimpaired (\<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/ Posterior Tibial Artery) 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 lactating, pregnant or planning to become pregnant during the course of the study 4. Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with: 1. Osteomyelitis including and/or proximal to the metatarsal head 2. Gangrene involving the plantar skin of the forefoot, midfoot,or heel 3. Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel 4. Full thickness heel ulcer with/without calcaneal involvement 5. Any wound with calcaneal bone involvement 6. Wounds that are deemed to be neuropathic or non-ischemic in nature 7. Wounds that would require flap coverage or complex wound management for large soft tissue defect 8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone 5. Prior bypass surgery of target vessel 6. Planned amputation of the target limb (major) 7. Previously implanted stent in the target lesion 8. Vulnerable or protected adults 9. Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents 10. Known allergy to sirolimus 11. Subjects with severe (Stage 4) renal disease, defined eGFR \< 30. Intraoperative exclusion criteria: 12. Failure to successfully cross the target lesion with a guide wire 13. Target vessel has lesions extending beyond the ankle joint 14. Failure to obtain \<30% residual stenosis prior to randomization 15. Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach. 16. Use of commercially available DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons). For Inflow and non-target lesions all the approved devices are allowed.
Contact & Investigator
Sahil Parikh, MD
STUDY CHAIR
New York-Presbyterian/Columbia University Irving Pavilion
Frequently Asked Questions
Who can join the NCT06182397 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Arterial Disease of Legs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06182397 currently recruiting?
Yes, NCT06182397 is actively recruiting participants. Contact the research team at farhana@conceptmedical.com for enrollment information.
Where is the NCT06182397 trial being conducted?
This trial is being conducted at Scottsdale, United States, Los Angeles, United States, Los Angeles, United States, Clearwater, United States and 11 additional locations.
Who is sponsoring the NCT06182397 clinical trial?
NCT06182397 is sponsored by Concept Medical Inc.. The principal investigator is Sahil Parikh, MD at New York-Presbyterian/Columbia University Irving Pavilion. The trial plans to enroll 368 participants.