Status:
RECRUITING
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
Lead Sponsor:
Concept Medical Inc.
Conditions:
Arterial Disease of Legs
Below-the-knee Obstruction
Eligibility:
All Genders
21+ years
Phase:
NA
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 subject...
Detailed Description
The burden of limb loss because of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty ...
Eligibility Criteria
Inclusion
- Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \> 21 years OR adulthood minimum age (depending on the US state regulations)
- Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
- Rutherford class 5 to 6 in the target limb with documented WIFI score.
- Intraoperative
- 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.
- 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
- Comorbid conditions limiting life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
- Subject is lactating, pregnant or planning to become pregnant during the course of the study
- Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with:
- Osteomyelitis including and/or proximal to the metatarsal head
- Gangrene involving the plantar skin of the forefoot, midfoot,or heel
- Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
- Full thickness heel ulcer with/without calcaneal involvement
- Any wound with calcaneal bone involvement
- Wounds that are deemed to be neuropathic or non-ischemic in nature
- Wounds that would require flap coverage or complex wound management for large soft tissue defect
- Full thickness wounds on the dorsum of the foot with exposed tendon or bone
- Prior bypass surgery of target vessel
- Planned amputation of the target limb (major)
- Previously implanted stent in the target lesion
- Vulnerable or protected adults
- Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents
- Known allergy to sirolimus
- Subjects with severe (Stage 4) renal disease, defined eGFR \< 30.
- Intraoperative exclusion criteria:
- Failure to successfully cross the target lesion with a guide wire
- Target vessel has lesions extending beyond the ankle joint
- Failure to obtain \<30% residual stenosis prior to randomization
- Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.
- 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.
Key Trial Info
Start Date :
January 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT06182397
Start Date
January 16 2025
End Date
February 1 2031
Last Update
January 2 2026
Active Locations (29)
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1
Honor Health Research & Innovation Institute
Scottsdale, Arizona, United States, 85258
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of California Los Angeles
Los Angeles, California, United States, 90095
4
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756