Post-Market Clinical Follow-Up (PMCF) Study Plan -BeGraft Aortic Stent Graft System

• Conditions: Aortic stenosis; Q28; Q25.1; Other congenital malformations of circulatory system; Coarctation of aorta

• Registration Number: DRKS00013959
• Lead Sponsor: Bentley InnoMed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-08
• Study Completion: 2020-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

The BeGraft Aortic Stent Graft System” is indicated for - the implantation in the native and/or recurrent coarctation of the aorta (CoA*) on adolescent or adult patients with the following clinical conditions:
-- Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or noninvasive imaging, i.e. echocardiography, magnetic resonance imaging (MRI), CT scan;
-- Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function;
-- Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated;
-- Stenosis diameter <20% of the adjacent vessel diameter. Stenosis that would present increased risk of vascular damage of disruption.
- and furthermore for restoring and improving the patency of the iliac arteries.

Exclusion Criteria

1. When PTA is technically not possible (e. g. not feasible to access the lesion with guide wire or balloon catheter)
2. Patients too small to allow safe delivery of the Stent Graft without compromise to the systemic artery used for delivery
3. Clinical or biological signs of infection
4. Active endocarditis
5. Known allergy to aspirin, other antiplatelet agents, or heparin
6. Pregnancy
7. Aneurysms immediately adjacent to the site of Stent Graft implantation
8. Stenosis distal to the site of Stent Graft implantation
9. Lesions in or adjacent to essential collateral(s)
10. Lesions in locations subject to external compression
11. Heavily calcified lesions resistant to PTA
12. Patients with diffuse distal disease resulting in poor Stent Graft outflow
13. Patients with a history of coagulation disorders
14. Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant / antiplatelet therapy and / or non-responders to anticoagulant / antiplatelet therapy
15. Fresh thrombus formation
16. Patients with known hypersensitivity to the stent material (cobalt-chromium (L605)) and / or ePTFE

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of aortic/iliac diameter, pre and post stent implantation (dilatation of the narrowest segment of the coarctation by more than 50%).<br>Data will be assessed by angiographic or echography examinations.<br>

Secondary Outcome Measures

Name	Time	Method
Device-related, access site-related and target site-related procedural complications will be recorded by physical examination and echography. Duration of the assessment starts with the procedure and ends 12 month after stent implantation.