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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
201
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 The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.
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 The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.
Heart Center, Segeberger Kliniken
Bad Segeberg, Germany
Heart Center Leipzig - University of Leipzig
Leipzig, Germany
Evangelisches Krankenhaus Paul Gerhardt Stift
Wittenberg, Germany
Percent Diameter Stenosis (DS)
Percent DS of the target segment assessed by quantitative coronary angiography (QCA)
Time frame: 6 months
Target lesion failure
Taget lesion failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, coronary artery bypass graft and clinically driven target lesion revascularization
Time frame: 1 month, 6 months, 1 year and 2 years
Target vessel failure
Target vessel failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, and clinically driven target vessel revascularization
Time frame: 1 month, 6 months, 1 year and 2 years
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Mater Private Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Centro Cardiologico Monzino
Milan, Italy
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Royal Bournemouth hospital
Bournemouth, United Kingdom
...and 5 more locations