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A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.

NCT07359807 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2026-04-17

No results posted yet for this study

Summary

Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries. The long-term success of bare balloon PTA in the femoropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter.

The rationale of this trial is based on the hypothesis that the usage of the MagicTouch drug-coated balloon (DCB) is at least equal (non-inferior) with regard to efficacy and safety in comparison with a clinically well-established paclitaxel drug-coated balloon (PTX DCB).

The objective of this prospective, randomized, multi-center trial is to compare the Magic Touch® DCB with PTX DCBs for treatment of high-grade stenotic or occluded lesions in supeficial femoral artery (SFA) and/or P1 segment of the popliteal artery in PAD patients.

Conditions

  • Popliteal Artery Disease
  • Superficial Femoral Artery Disease

Interventions

COMBINATION_PRODUCT

Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter

Sirolimus is used outside the United States to block cell growth, cell proliferation (especially T-cells), and angiogenesis (new blood vessel formation). This experimental device uses proprietary technology to adhere sirolimus to the balloon catheter, deliver it to the affected vessel, and ultimately be absorbed by the surrounding tissue.

COMBINATION_PRODUCT

Paclitaxel drug-coated balloon angioplasty

Paclitaxel, which is used in cancer chemotherapy for various indications, is a drug that disrupts normal microtubule function and prevents neointimal hyperplasia by inhibiting smooth muscle cell migration, proliferation, and extracellular matrix secretion and is currently used in the United States.

Sponsors & Collaborators

  • Concept Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Farhana Siddique · Concept Medical Inc.

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

  • Eric A Secemsky, MD · Beth Israel Deaconess Medical Center

  • Brain DeRubertis, MD · New York Presbyterian - Weill Cornell Medical Center

  • Edward Choke, PhD · Sengkang General Hospital

  • Masahiko Fujihara, MD · Kishiwada Tokushukai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2033-01-31
FDA Drug
Yes
FDA Device
Yes

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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 NCT07359807 on ClinicalTrials.gov