BGP+ Stent as Bridging Stent in BEVAR

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
• Intervention / Treatment: Device: BGP+ Stent Graft System as bridging stent

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Litterscheid; Phone Number: +4915785319015; Email: sarah.litterscheid@fcre.eu
• Study Contact Backup: Name: Sabrina Overhagen; Phone Number: +4915785319015; Email: info@fcre.eu

Study Locations

• Germany
  • Aachen, Germany
    • Alexander Gombert
  • Hamburg, Germany
    • University Hospital Eppendorf, UKE Hamburg
  • Leipzig, Germany
    • University Hospital Leipzig
  • Munich, Germany
    • University Hospital LMU Munich
  • Münster, Germany, 48145
    • St. Franziskus Hospital
  • Nürnberg, Germany
    • Klinikum Nürnberg Süd
  • Regensburg, Germany
    • Karin Pfister
  • Stuttgart, Germany
    • Hospital Stuttgart
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie
  • bW
    • Heidelberg, bW, Germany, 69120
      • Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGP+ Stent Graft System; Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms	Device: BGP+ Stent Graft System as bridging stent; BGP+ Stent Graft System as bridging stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30 days post-op
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
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
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
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
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
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
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
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
Freedom from aneurysm related mortality post-procedure		1 day post-op, 6-, 12-, 24- months post-op
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
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
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

Collaborators and Investigators

• Sponsor: Dr. Sabrina Overhagen
• Collaborators: Bentley InnoMed GmbH
• Investigators: Principal Investigator: Martin Austermann, PD. Dr., Foundation for Cardiovascular Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Estimated): May 9, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Aortic Diseases; Aortic Aneurysm, Abdominal; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: FCRE-190129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No