BGP+ Stent as Bridging Stent in BEVAR

Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture Clinical Trial

Official title:

Physician-Initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System as Bridging Stent in BEVAR for Complex Aortic Aneurysms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03982940
• Other study ID #: FCRE-190129
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: FCRE (Foundation for Cardiovascular Research and Education)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: July 31, 2025
• Est. primary completion date: May 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Rupture
• Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Intervention

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

Locations

Country	Name	City	State
Germany	Alexander Gombert	Aachen
Germany	University Hospital Eppendorf, UKE Hamburg	Hamburg
Germany	Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie	Heidelberg	bW
Germany	Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie	Kiel	Schleswig-Holstein
Germany	University Hospital Leipzig	Leipzig
Germany	University Hospital LMU Munich	Munich
Germany	St. Franziskus Hospital	Münster
Germany	Klinikum Nürnberg Süd	Nürnberg
Germany	Karin Pfister	Regensburg
Germany	Hospital Stuttgart	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Sabrina Overhagen	Bentley InnoMed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy endpoint (1) - Technical success	defined as successfully introduction and deployment of the BGP+ balloon expandable covered Stent Graft System implanted as bridging stent in BEVAR	1 day post-op
Primary	Efficacy endpoint (2) - Bridging stent patency at 12 months	defined as absence of restenosis (=50% stenosis) or sole target vessel occlusion based on CT angio at 12 months	12 months post-op
Primary	Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months	Absence of procedure related complications and bridging stent related endoleaks at 12 months	12 months post-op
Secondary	Bridging stent patency post-procedure	defined as absence of restenosis (=50% stenosis) or sole target vessel occlusion based on Duplex Ultrasound or CT Angio	1 day post-op, 6- and 24- months post-op
Secondary	Freedom from bridging stent related endoleaks post-procedure	Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography)	1 day post-op, 6- and 24- months post-op
Secondary	Freedom from bridging stent related secondary intervention	Freedom from bridging stent related secondary intervention	1 day post-op, 6-, 12- and 24- months post-op
Secondary	Freedom from type I & III endoleaks post-procedure post-procedure	Freedom from type I & III endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography)	1 day post-op, 6-, 12-, and 24- months post-op
Secondary	30-day mortality		30 days post-op
Secondary	Freedom from stent graft migration	defined as freedom from stent graft migration (more than 10 mm)	1 day post-op, 6-, 12 -and 24- months post-op
Secondary	Freedom from AAA diameter increase	defined as more than 5mm increase in maximum diameter measured at 6-, 12- and 24- months as compared to post-op implantation, based on imaging (duplex ultrasound or CT Angiography)	6-, 12- and 24- months post-op
Secondary	Freedom from aneurysm related secondary endovascular procedures	Freedom from aneurysm related secondary endovascular procedures post-op	1 day post-op, at 6-, 12- and 24- months post-op
Secondary	Freedom from conversion to open surgical repair post-procedure	Freedom from conversion to open surgical repair post-op and at 6, 12 and 24 months	1 day post-op, 6-, 12-, 24- months post-op
Secondary	Freedom from aneurysm related mortality post-procedure		1 day post-op, 6-, 12-, 24- months post-op
Secondary	Freedom from aneurysm rupture post-implantation	Freedom from aneurysm rupture within 12- and 24-months post-implantation	up to 12- and 24- months post-op
Secondary	Freedom from any major adverse events post-procedural and at 6 and 12 months		1 day post-op, 6-, 12- and 24- months post-op
Secondary	Health Related Quality of Life scores	Health Related Quality of Life scores at 12- and 24 months post implantation	12- and 24- months post-op