Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary (Artery) Disease
- In Stent Restenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients who meet all the eligibility criteria will be randomized 2:1 to receive treatment with either a BA9-DCB or a Sequent Please® Paclitaxel Coated Balloon.Masking: Single (Participant)Masking Description: The subject will be blinded to the study treatment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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 pro...
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.
Tracking Information
- NCT #
- NCT04079192
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Robert A Byrne, MD, PhD Mater Private Hospital
Get Well Soon