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

NCT06182397 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2026-01-02

No results posted yet for this study

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 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).

Conditions

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

Interventions

DEVICE

MagicTouch PTA Sirolimus drug coated balloon

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.

DEVICE

Placebo balloon angioplasty

For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.

Sponsors & Collaborators

  • Concept Medical Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2026-12-01
Completion
2031-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06182397 on ClinicalTrials.gov