Clinical Trial

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

Study acronym: FUTURE-BTK
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-08-10; most recent amendment 2025-06-30.
Status change: Not Yet Recruiting → Recruiting 2020-08-28
Trial Details
NCT Number NCT04511247
Lead Sponsor Concept Medical Inc.
Conditions Peripheral Artery Disease, Atherosclerosis, Arterial Disease of Legs
Enrollment 219 participants
Start Date 2020-08-15
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-03