NCT04079192

Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study

A Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9TM Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.

Detailed description

This clinical trial will serve as a first-in-human (FIH) experience for the BA9™ DCB in a population of patients with coronary artery disease who have an indication for interventional treatment of in-stent restenosis (ISR) in a bare-metal stent (BMS) or drug-eluting stent (DES). The study uses a prospective, multi-center, single blind, randomized controlled trial design to enroll 195 patients. The study will seek to prove that the BA9-DCB is non-inferior to the approved CE marked Sequent Please® Paclitaxel Coated Balloon with respect to % Diameter Stenosis and has similar safety characteristics.

Conditions

• Coronary Artery Disease
• In-Stent Restenosis

Interventions

Type	Name	Description
DEVICE	Biolimus A9 Drug Coated Balloon	A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.
DEVICE	SeQuent Please Paclitaxel Drug Coated Balloon	A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Timeline

• Start date: 2020-08-07
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2019-09-06
• Last updated: 2022-08-10

Locations

15 sites across 5 countries: Germany, Ireland, Italy, Spain, United Kingdom