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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MagicTouch PTA Sirolimus drug coated balloon — DEVICE
  All patients must first be treated with pre dilatation with a standard balloon angioplasty using any standard balloon catheters at the discretion of the operator. Magic Touch PTA Sirolimus coated balloon catheter is an adjunct treatment that should be used in combination with standard balloon angioplasty. Following successful crossing of wire across the lesion and plain balloon angioplasty of arterial lesion with successful lesion preparation with residual lesion \<30%, subjects will be randomized to receive study device balloon. If patients are assigned to MagicTouch PTA Sirolimus DCB, the Angioplasty of lower limb will be performed with this device in addition to standard balloon angioplasty.
• Placebo balloon angioplasty — DEVICE
  For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.

Study Details

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).

Key Dates

Start date

Jan 16, 2025

Status verified

Dec 2025

Primary completion

Dec 1, 2026

Completion

Feb 1, 2031

Study Design

Enrollment

368 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: MagicTouch PTA sirolimus DCB
  MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
• Placebo Comparator: Placebo balloon angioplasty
  Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)

Primary Outcome Measure

Primary patency at 12 months defined as freedom from Target Vessel Occlusion, Binary Restenosis, Clinically-Driven Target Lesion Revascularization and Major Amputation. [ Time Frame: 12 months ]

Central Contacts

• Farhana Siddique
  +919725495366
  [email protected]
• Dario Gattuso
  +393292467132
  [email protected]

Locations (29)

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