Clinical trial NCT03982940: BGP+ Stent as Bridging Stent in BEVAR
Official title: Physician-Initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System as Bridging Stent in BEVAR for Complex Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
Collaborators: name: Bentley InnoMed GmbH
First posted: 2019-06-12
Enrollment: 118
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy endpoint (1) - Technical success
timeFrame: 1 day post-op
measure: Efficacy endpoint (2) - Bridging stent patency at 12 months
timeFrame: 12 months post-op
measure: Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months
timeFrame: 12 months post-op
Secondary outcomes:
measure: Bridging stent patency post-procedure
timeFrame: 1 day post-op, 6- and 24- months post-op
measure: Freedom from bridging stent related endoleaks post-procedure
timeFrame: 1 day post-op, 6- and 24- months post-op
measure: Freedom from bridging stent related secondary intervention
timeFrame: 1 day post-op, 6-, 12- and 24- months post-op
measure: Freedom from type I & III endoleaks post-procedure post-procedure
timeFrame: 1 day post-op, 6-, 12-, and 24- months post-op
measure: 30-day mortality
timeFrame: 30 days post-op
measure: Freedom from stent graft migration
timeFrame: 1 day post-op, 6-, 12 -and 24- months post-op
measure: Freedom from AAA diameter increase
timeFrame: 6-, 12- and 24- months post-op
measure: Freedom from aneurysm related secondary endovascular procedures
timeFrame: 1 day post-op, at 6-, 12- and 24- months post-op
measure: Freedom from conversion to open surgical repair post-procedure
timeFrame: 1 day post-op, 6-, 12-, 24- months post-op
measure: Freedom from aneurysm related mortality post-procedure
timeFrame: 1 day post-op, 6-, 12-, 24- months post-op
measure: Freedom from aneurysm rupture post-implantation
timeFrame: up to 12- and 24- months post-op
measure: Freedom from any major adverse events post-procedural and at 6 and 12 months
timeFrame: 1 day post-op, 6-, 12- and 24- months post-op
measure: Health Related Quality of Life scores
timeFrame: 12- and 24- months post-op
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie
state: bW
city: Kiel
country: Germany
facility: Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie
state: Schleswig-Holstein
city: Aachen
country: Germany
facility: Alexander Gombert
city: Hamburg
country: Germany
facility: University Hospital Eppendorf, UKE Hamburg
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Munich
country: Germany
facility: University Hospital LMU Munich
city: Münster
country: Germany
facility: St. Franziskus Hospital
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Regensburg
country: Germany
facility: Karin Pfister
city: Stuttgart
country: Germany
facility: Hospital Stuttgart
Study officials:
affiliation: Foundation for Cardiovascular Research and Education
name: Martin Austermann, PD. Dr.
role: PRINCIPAL_INVESTIGATOR
References: