Open-Label Post-Marketing Surveillance Study to access safety and efficacy of the BeGraft Coronary Stent Graft System”

Firma Bentley InnoMed GmbH0 个研究点目标入组 30 人开始时间: 2012年11月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

发起方

Firma Bentley InnoMed GmbH