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Sirolimus coated balloon treatment for below the knee arterial disease

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

NA · Concept Medical Inc. · NCT06182397

This study is testing if a special balloon coated with a drug can help people with below the knee arterial disease have better results than the usual balloon treatment.

Quick facts

PhaseNA
Study typeInterventional
Enrollment368 (estimated)
Ages21 Years and up
SexAll
SponsorConcept Medical Inc. (industry)
Locations29 sites (Scottsdale, Arizona and 28 other locations)
Trial IDNCT06182397 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a sirolimus drug coated balloon (DCB) compared to standard balloon angioplasty for treating below the knee arterial disease. It is a randomized, placebo-controlled, single-blind trial conducted at approximately 70 sites, primarily in the USA, Singapore, Australia, and Japan. Eligible participants will be randomly assigned to receive either the sirolimus DCB in addition to standard angioplasty or a placebo balloon angioplasty. The study aims to determine if the sirolimus DCB can provide better outcomes in terms of reducing restenosis and improving limb health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 21 years old with Rutherford class 4 to 6 peripheral arterial disease and specific lesion characteristics in below the knee arteries.

Not a fit: Patients with less severe arterial disease or those who do not meet the inclusion criteria, such as those with flow-limiting lesions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from below the knee arterial disease by reducing the risk of restenosis.

How similar studies have performed: Previous studies have shown success with drug coated balloons in other vascular areas, but the efficacy of sirolimus DCBs below the knee is still being evaluated, making this approach somewhat novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Arterial Disease of Legs, Below-the-knee Obstruction, PAD - Peripheral Arterial Disease, below the knee, PTA, Angioplasty, lower limb

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.