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SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease

NCT04511247 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2025-07-03

No results posted yet for this study

Summary

This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of below the knee arterial disease.

Conditions

Interventions

DEVICE

MagicTouch PTA Sirolimus drug coated balloon

For participants randomised to MagicTouch PTA sirolimus DCB, following successful plain balloon angioplasty of the arterial lesion (defined as \<30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), MagicTouch sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.

DEVICE

POBA balloon

For participants randomised to the standard balloon angioplasty group, a placebo standard balloon which is identical to the SCB will also be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty

Sponsors & Collaborators

  • Concept Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Edward Choke · Sengkang General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Singapore
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT04511247 on ClinicalTrials.gov