Study of the Orsiro Drug Eluting Stent System (BIOFLOW-II)

Biotronik

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: Percutaneous Coronary Intervention (Orsiro DES); Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01356888

C1004

Details and patient eligibility

About

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

Enrollment: 452 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Subject has provided a written informed consent
• Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
• The target lesion length is ≤ 26 mm
• The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm

Main Exclusion Criteria:

• Evidence of myocardial infarction within 72 hours prior to index procedure
• Unprotected left main coronary artery disease (stenosis >50%)
• Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
• Target lesion involves a side branch > 2.0 mm in diameter
• Heavily calcified lesion
• Target lesion is located in or supplied by an arterial or venous bypass graft

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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452 participants in 2 patient groups

Abbott Laboratories - Xience Prime DES

Active Comparator group

Treatment:

Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)

Biotronik - Orsiro DES

Experimental group

Treatment:

Device: Percutaneous Coronary Intervention (Orsiro DES)