Vascular Implant Safety and Efficacy Study

Biotronik CRC Inc.5 sites in 1 country66 target enrollmentAugust 14, 2017

Overview

Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions

Registry

clinicaltrials.gov

Start Date

August 14, 2017

End Date

January 28, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Subject is \> 18 years and \< 85 years old
•Written subject informed consent
•Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients
•Subject is eligible for percutaneous coronary intervention (PCI)
•Subject is acceptable candidate for coronary artery bypass surgery
•Subject is eligible for Dual Anti Platelet Therapy (DAPT)
•Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure
•Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation.
•Target lesion length up to 22 mm by visual estimation.
•Target lesion with ≥ 50% and \< 100% stenosis by visual estimation

•Left main coronary artery disease
•Three-vessel coronary artery disease at the time of index procedure
•Angiographic evidence of thrombus in target vessel
•Chronic total occlusion
•Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon
•Bifurcation lesion requiring side branch intervention, if side branches \> 2mm in diameter are involved
•Ostial lesions (within 5 mm of vessel origin)
•In-stent restenosis
•Lesions with prior treatment with a drug coated balloon (DCB)
•Target lesion is located in or supplied by an arterial or venous bypass graft