Health Condition 1: null- Coronary Artery Occlusion
Conditions
Interventions
Intervention1: Percutaneous Transluminal Coronary Angioplasty: Biolimus A9 Eluting Stent in general population. Drug is secreted till 6 to 9 months of deployment of stent. Dose of the drug is 15.6 mic
Sponsors
Biosensors Europe SA Moges Switzerland
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients that need a treatment with a BioMatrix drug-eluting stent; 2. Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents; 3. No limitation on the number of treated lesions, and vessels, and lesion length.
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent; 2. Patients needing additional stent NOT of the BioMatrix type; 3. Patients receiving next to the BioMatrix stent also other coronary, vascular interventions, for example dilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Registry device oriented major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and Non-Q-wave), or justified target vessel revascularization.Timepoint: At 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Primary and secondary stent thrombosis (definite and probable according to ARC definitions); 2.Registry device oriented major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and Non-Q-wave), or justified TVR; 3.Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q- wave and non-Q wave), or any clinically driven TVR; Death and MI and TVR Timepoint: At 1, 6, 12 and 24 months | — |
Countries
India
Contacts
Public ContactDr Hrishikesh Rangnekar
Biosensors International
Outcome results
None listed