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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Biosensors Europe SA
- Enrollment
- 201
- Locations
- 15
- Primary Endpoint
- Percent Diameter Stenosis (DS)
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients presenting with in-stent restenosis (ISR) and clinical symptoms of ischemia and/or (i) evidence of ischemia on non-invasive testing or (ii) hemodynamically relevant lesion defined by FFR ≤ 0.80 or iFR ≤ 0.89 or \> 90% stenosis.
- •Patient presenting with a lesion that can be fully covered with one DCB length. - Patients can have up to two index lesions with ISR, which can both be treated and evaluated.
- •Patient has provided written informed consent
- •Age ≥ 18 years.
- •Patient is willing and able to comply with the study procedures and follow-up.
Exclusion Criteria
- •Patient presents with a ST-elevation myocardial infarction (STEMI) or had an acute MI within 48 hours prior to presentation (according to the universal definition of myocardial infarction).
- •Patient with acute cardiac decompensation or acute cardiogenic shock
- •Documented left ventricular ejection fraction (LVEF) ≤ 30%
- •Patient with impaired renal function (glomerular filtration rate \< 80 mL/min/1.73 m2).
- •More than 2 epicardial vessels requiring revascularization
- •Significant left main stenosis (by visual estimation) or an ISR located in the left main (LM).
- •Patient has an ISR lesion that cannot be covered with one DCB length.
- •Patient has an ISR in the target segment in a stent of a smaller diameter than 2.5mm.
- •Severe calcification that might prevent a sufficient expansion of the DCB, if not pre-treated with rotablation or a shockwave application device.
- •Known hypersensitivity or contraindication to biolimus, paclitaxcel, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
Outcomes
Primary Outcomes
Percent Diameter Stenosis (DS)
Time Frame: 6 months
Percent DS of the target segment assessed by quantitative coronary angiography (QCA)
Secondary Outcomes
- Target lesion failure(1 month, 6 months, 1 year and 2 years)
- Target vessel failure(1 month, 6 months, 1 year and 2 years)