Sirolimus-Coated Balloon Vs. Standard Balloon Angioplasty in Below-The-Knee Arterial Disease

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental balloon device is effective in treating peripheral arterial disease (insufficient blood flow in the legs). The device, called Magic Touch PTA, is covered with a drug called sirolimus and can deliver sirolimus to blood vessels. Sirolimus is approved by the U.S. Food and Drug Administration (FDA) and belongs to a class of medications that blocks cell growth and division. The device uses very small particles attached to the balloon portion of the catheter to deliver the treatment drug (sirolimus) into affected narrowed areas of arteries below the knee. Participants will be randomly assigned to receive either the sirolimus drug-coated balloon or a non-sirolimus drug-coated balloon (placebo or standard balloon) after angioplasty procedure of the leg arteries.

Eligibility

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.

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.
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.
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.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

MAGICAL BTK: Randomized Controlled Trial of MAGICTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Study Details

Disease Type/Condition

Other

Principal Investigator

Dohad, Suhail

Age Group

Adult

Phase

N/A

IRB Number

STUDY00003626

ClinicalTrials.gov ID

NCT06182397

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org