BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry

Biotronik

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Myocardial Ischemia

Treatments: Device: Orsiro Mission DES

Study type: Observational

Funder types: Industry

Identifiers

NCT04555174

C1902

Details and patient eligibility

About

The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Full description

BIOFLOW-VIII is a national, prospective, non-randomized, multi-center, open-label registry to confirm both, the acute performance as well as the mid- and long-term safety and clinical performance of the Orsiro Mission stent in an all-comers patient population within daily clinical practice.

A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone.

A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge.

Enrollment: 872 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic coronary artery disease intended to be treated with an Orsiro Mission DES (silent ischemia is permitted)
• Subject has signed informed consent for data release
• Subject is geographically stable and willing to participate at all follow up assessments
• Subject is ≥ 18 years of age

Exclusion criteria

• Subject did not sign informed consent for data release
• Pregnancy
• Known allergy (which cannot be pre-treated) to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt- chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), silicon carbide, PLLA, mTOR inhibiting drugs such as sirolimus, or contrast media

Trial design

872 participants in 1 patient group

Orsiro Mission DES

Description:

All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months.

Treatment:

Device: Orsiro Mission DES