Clinical Trial

Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease

Study acronym: FUTURE-SFA
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 3, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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 superficial and popliteal arterial disease.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2020-08-10; most recent amendment 2025-06-30.
Status change: Not Yet Recruiting → Recruiting 2020-09-12
Trial Details
NCT Number NCT04511234
Lead Sponsor Concept Medical Inc.
Conditions Peripheral Artery Disease, Atherosclerosis, Arterial Disease
Enrollment 279 participants
Start Date 2020-09-08
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-03