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)

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.

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.

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.
• Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
• Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
• Anticipated difficulties to complete the angiographic follow-up study.
• Patient with a life expectancy of less than 12 months.
• Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.