Open-Label Post-Marketing Surveillance Study to access safety and efficacy of the BeGraft Coronary Stent Graft System”
- Conditions
- I20-I25Ischaemic heart diseases
- Registration Number
- DRKS00004540
- Lead Sponsor
- Firma Bentley InnoMed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 30 Day Occurrence of MACE:<br>• Death<br>• Post procedural target vessel related Q-Wave Myocardial Infarction<br>• Emergency CABG<br>• Stent Thrombosis<br>
- Secondary Outcome Measures
Name Time Method Acute Performance Endpoints:<br>• Successful sealing of acute perforation or rupture of coronary arteries<br>• Successful treatment of aneurysm of coronary arteries or coronary bypass-vein graft<br>• Patency (angiographic/visual check);<br>Angiographic Endpoints at 6-8 Months:<br>• Binary in-segment restenosis <br>• Binary In-stent restenosis <br>• In-stent late lumen loss;<br>Clinical Endpoints at 12 Months:<br>• Death<br>• MI<br>• Stent Thrombosis<br>• Target lesion revascularization at 12 months<br>
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