BGP+ Stent as Bridging Stent in BEVAR

Marc Bosiers, MD

Status: Active, not recruiting

Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Treatments: Device: BGP+ Stent Graft System as bridging stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03982940

FCRE-190129

Details and patient eligibility

About

The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BGP+ balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in BEVAR (branched endovascular aortic repair) for complex aortic aneurysms.

Enrollment: 118 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient eligible for elective repair of TAAA with BEVAR in accordance with the applicable guidelines for vascular interventions (e.g. Aneurysm size 6cm or aneurysm growth of >5mm within 6 months or 1cm within 1 year)

2. Patient is willing to comply with specified follow-up evaluations at the specified times

3. Patient is >55 years old

4. Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the trial

   • Patient has a projected life-expectancy of at least 12-months

5. Patient needs to have a landing zone in their target vessel of at least 15 mm, and coverage/ wall adaptation of the BGP+ should be obtained for at least 10 mm.

6. The access vessel for introduction of the sheath through which the BGP+ will be advanced should be at least 3mm (it should be able to fit a 8F sheath)

7. No early important division branch from the target vessel with risk of coverage

8. Absence of pre-existing dissection in the target vessels

9. Target vessels (renal arteries, superior mesenteric artery, and celiac trunk) for the BGP+ must have a diameter between 5 and 10 mm

10. Aortic endoprosthesis with inner branches (can be hybrid or branches only)

11. Hybrid aortic endoprosthesis with fenestrations and branches (at least 2 and only the target vessels which are connected by a branch shall be treated with a study device within this study)

12. At least one target vessel is bridged with only one BGP+ (relining allowed)

13. Full compliance with all inclusion criteria/exclusion criteria and all intraoperative criteria

Exclusion criteria

1. Previously implanted stent in the target vessel
2. Renal artery with >100° cranial orientation
3. Patients refusing treatment
4. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
5. Patients with uncorrected bleeding disorders or heparin induced thrombocytopenia
6. Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding
7. Any planned surgical intervention/procedure within 30 days of the trial procedure
8. Patients with rupture or any patient considered to be hemodynamically unstable at onset of procedure
9. Patient is currently participating in another conflicting investigational drug or device trial that has not completed the entire follow up period.
10. Patients with diffuse distal disease resulting in poor stent outflow
11. Fresh thrombus formation within the last 14 days
12. Patients with known hypersensitivity to the stent material (L605) and/or PTFE
13. Hybrid Approach (endovascular in combination with open surgery)
14. Patients with a connective tissue disorder
15. Patients with mycotic or inflammatory aneurysm
16. Myocardial infarction or stroke within 3 months prior to the procedure
17. Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
18. Patients with ASA classification 5 or higher
19. Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
20. Patients with increased risk of intraoperative rupture
21. Patients with access vessel which are too tortuous, narrow or any kind of reason that would lead to failure of introducing and advancing an introducer sheath

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

BGP+ Stent Graft System

Experimental group

Description:

Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms

Treatment:

Device: BGP+ Stent Graft System as bridging stent