BIOFLOW III Satellite-Italy Orsiro Stent System

Biotronik

Status: Completed

Conditions: Coronary Artery Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT02028728

G1307

Details and patient eligibility

About

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).

Full description

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical Performance.

Enrollment: 609 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic coronary artery disease
• Subject 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
• Pregnancy
• Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
• Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
• Currently participating in another study and primary endpoint not reached yet

Trial design

609 participants in 1 patient group

Orsiro