BIOFLOW-III Canada Satellite Registry

NCT ID: NCT01880242

Last Updated: 2017-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-13
• Study Completion Date: 2017-08-31

Brief Summary

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil 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%-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%-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 neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a 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. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Orsiro DES

Subjects requiring coronary revascularization with Drug Eluting Stents (DES). subgroups: Subjects presenting with

1. Diabetes (all types)

2. Small vessels (≤2.75 mm)

3. Chronic total occlusion (CTO)

4. Acute Myocardial Infarction (incl. STEMI and NSTEMI)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Symptomatic coronary artery disease or documented silent ischemia
• Subject informed consent for data release
• Subject is geographically stable and willing to participate at all follow ups assessments

Exclusion Criteria

• Subject did not sign informed consent for data release
• Pregnancy
• Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation/antiplatelet therapy required for PCI, stainless steel, sirolimus
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik Canada Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samer Mansour, Dr, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

St. Michael's Hospital

Toronto, , Canada

Countries

Canada

Other Identifiers

G1207

Identifier Type: -

Identifier Source: org_study_id