Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent (BIOFLOW-IV)

Biotronik

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Device: Abbott Laboratories Xience

Device: Biotronik Orsiro

Study type

Interventional

Funder types

Industry

Identifiers

NCT01939249

C1204

Details and patient eligibility

About

BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.

Enrollment

585 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Subject must provide written informed consent
The target reference vessel diameter (RVD) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online QCA.
Target lesion length is ≤ 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent
Single de novo lesion with ≥ 50% and < 100% stenosis in up to 2 coronary arteries

Main Exclusion Criteria:

Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
Planned intervention of non-target vessel(s) within 30 days after the index procedure
Planned intervention of target vessel(s) after the index procedure
Target lesion is located in the left main
Target lesion is located in or supplied by an arterial or venous bypass graft
Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online QCA
Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off