BIOTRONIK-Safety And Clinical Performance Of The Drug ElutingOrsiro Stent In The Treatment Of Patients With Single De NovoCoronary Artery Lesions In An INDIAN Population - BIOFLOW INDIA

BIOTRONIK AG0 sites120 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•Patient has provided a written informed consent
•2\. Patient is ≥ 18 and ≤80 years old
•3\. Single de novo lesion with ≥50% and 100% stenosis in up to 2 coronary arteries
•4\. Patient, target vessel(s) and lesion(s) are eligible for PCI with the Orsiro stent
•5\. The target lesion length is ≤26 mm (assessed either visually or by online QCA) and can be covered by one clinical investigation stent
•6\. The target reference vessel diameter is ≥2\.0 mm and ≤ 4\.0 mm (assessed either visually or by online QCA)
•7\. Target vessel(s) with TIMI flow ≥2
•8\. Patient is an acceptable candidate for CABG
•9\. Clinical evidence of stable or unstable angina pectoris or documented silent ischemia
•10\. Eligible for DAPT treatment with ASA plus either, Clopidogrel, Prasugrel, Ticlopidineor Ticagrelor

•Pregnant and/or breast\-feeding females or females who intend to become pregnant during the time of the clinical investigation
•2\. Evidence of myocardial infarction within 72 hours prior to the index procedure
•3\. Patients with CKMB and/or Troponin levels exceeding the normal range within 24 hours prior to the procedure
•4\. Unprotected Left Main coronary artery disease (stenosis 50%)
•5\. Three\-vessel coronary artery disease at time of procedure
•6\. Thrombus in target vessel
•7\. Planned interventional treatment of any non\-target vessel within 30 days post\-procedure.
•8\. Planned intervention of the target vessels after the index
•9\. Ostial target lesion (within 5\.0mm of vessel origin)
•10\. Target lesion involves a side branch 2\.0mm in diameter