I20-I25
Conditions
Interventions
Group 1: BeGraft Coronary Stent Graft System
Sponsors
Firma Bentley InnoMed GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with acute perforation or rupture of coronary arteries, or 2. Aneurysm of coronary arteries or coronary bypass-vein graft and 3. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
Exclusion criteria
Exclusion criteria: 1. Age < 18 years 2. Patients with hemorrhagic diathesis or other disorders in which the application of anticoagulant or antiplatelet therapy is contraindicated and patients unable or unwilling to tolerate anticoagulant / antiplatelet therapy (e.g. septic ulceration, cerebrovascular complications). 3. Patients with known allergies to the used materials: stent material (L605) and/or to the graft material PTFE and/or delivery system (stainless steel) material. 4. Severe allergic reaction to the contrast medium and/or the necessary pharmaceutical treatment (e.g. aspirin) or bleeding complications. 5. Previous enrollment in this trial. 6. Patient’s inability to fully comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 Day Occurrence of MACE: • Death • Post procedural target vessel related Q-Wave Myocardial Infarction • Emergency CABG • Stent Thrombosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute Performance Endpoints: • Successful sealing of acute perforation or rupture of coronary arteries • Successful treatment of aneurysm of coronary arteries or coronary bypass-vein graft • Patency (angiographic/visual check); Angiographic Endpoints at 6-8 Months: • Binary in-segment restenosis • Binary In-stent restenosis • In-stent late lumen loss; Clinical Endpoints at 12 Months: • Death • MI • Stent Thrombosis • Target lesion revascularization at 12 months | — |
Countries
Germany
Contacts
Public ContactN. Rifatov
Deutsches Herzzentrum München
Outcome results
None listed