Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Description

This is a Pivotal, Prospective, randomised, two arm, placebo controlled, single-blind, multicentre trial that will be conducted at approximately 70 sites; approx. 40 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Singapore, Australia and Japan. 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).

Conditions

Arterial Disease of Legs, Below-the-knee Obstruction, PAD - Peripheral Arterial Disease

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Study Overview

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Study Details

Study overview

This is a Pivotal, Prospective, randomised, two arm, placebo controlled, single-blind, multicentre trial that will be conducted at approximately 70 sites; approx. 40 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Singapore, Australia and Japan. 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).

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

Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Condition
Arterial Disease of Legs
Intervention / Treatment

-

Contacts and Locations

Davenport

Vascular Institute of the Midwest, Davenport, Iowa, United States, 52807

Lake Success

Northwell Health Long Island Jewish Medical Center, Lake Success, New York, United States, 11042

New York

The Mount Sinai Hospital, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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. Patients with severe (Stage 4) renal disease, defined eGFR \< 30%.

Ages Eligible for Study

21 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Concept Medical Inc.,

Sahil Parikh, MD, STUDY_CHAIR, New York-Presbyterian/Columbia University Irving Pavilion

Study Record Dates

2031-02-01