DRKS00004540Recruiting未知
Open-Label Post-Marketing Surveillance Study to access safety and efficacy of the BeGraft Coronary Stent Graft System”
Firma Bentley InnoMed GmbH0 sites30 target enrollmentStarted: November 29, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (—)
- Sex
- All
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
- •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.
Investigators
Similar Trials
Completed
Not Applicable
Safety and efficacy of a fixed dose combination of cefepime and amikaciosocomial pneumonia, febrile neutropenia, other bacterial infectionsInfections and InfestationsInfectionsISRCTN61799591Venus Remedies Limited (India)315
Active, not recruiting
Phase 4
A post-marketing surveillance study to evaluate the safety and immunological response of typhoid conjugate vaccine in healthy subjectsCTRI/2021/11/037996Cadila Healthcare Limited
Completed
Phase 4
A post-marketing study of the marketed product Maxtra® PDS syrup for the evaluation of safety and effects in children having common cold.CTRI/2021/02/031188Zuventus Healthcare Limited200
Completed
Phase 4
A post-marketing study of the marketed product Maxtra® P Oral Drops for the evaluation of safety and effects in children having common cold.CTRI/2021/02/031207Zuventus Healthcare Limited200
Active, not recruiting
Phase 4
A prospective, Post Marketing Surveillance study of omalizumab in Chronic Spontaneous UrticariaCTRI/2015/10/006247ovartis Healthcare Private Limited