NCT03769623: Brave

A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease

Completed NA Last updated 22 September 2021

What this trial tests

NA trial testing Biolimus in Coronary Artery Disease in 206 participants. Completed in 6 April 2021.

Timeline

25 June 2019

Primary endpoint
20 February 2021

6 April 2021

Quick facts

Lead sponsor	JW Medical Systems Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	206
Start date	25 June 2019
Primary completion	20 February 2021
Estimated completion	6 April 2021
Sites	1 location across China

Drugs / interventions tested

• Biolimus
• Powerline

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

JW Medical Systems Ltd

Who can join

Adults 18 to 75, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, multicenter, randomized, blind, parallel and superiority test study. It is planned to select 206 cases of subjects with small coronary artery vessel disease who meet the inclusion/exclusion criteria. They are randomly divide them into Biolimus release coronary balloon catheter treatment group and plain old balloon angioplasty catheter (Powerline) treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation. Follow-up with angiography is conducted at 9 months. The late lumen loss in diseased segment at 9 months after operation is the primary endpoint.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study.
   Xu K, Fu G, Tong Q, Liu B, et al · · 2022 · cited 31× · PMID 35738744 · DOI 10.1016/j.jcin.2022.03.024