BIOFLOW-III Canada Satellite Registry

NCT01880242 | Completed

• 1 other identifier: G1207
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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

Keywords

International; Multicenter; Observational registry; Orsiro Drug Eluting Stent (DES); Stenting; Treatment of Coronary Artery Disease; Coronary revascularization; Percutaneous Coronary Intervention (PCI); STEMI; NSTEMI; Ischemia; Angina; Subgroups; Acute Myocardial Infarction; Diabetes; Small Vessels; Chronic Total Occlusion (CTO)

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure

  Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)

  12 months

Secondary Outcomes (6)

• Target Lesion Failure

  6 and 12 months

• Target Vessel revascularization (TVR)

  6 and 12 months

• Target Lesion Revascularization (TLR)

  6 and 12 months

• Stent Thrombosis

  6 and 12 months

• Clinical Device Success

  1 day (At time of intervention)

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik Canada Inc: lead

Study Sites (2)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2W 1T8, Canada

Location

St. Michael's Hospital

Toronto, M5B1WG8, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Ischemia; Angina Pectoris; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Samer Mansour, Dr, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 18, 2013
• Study Start: May 13, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

CA (2)