Clinical trial NCT03987035: BGP Stent as Bridging Stent in FEVAR
Official title: Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System as Bridging Stent in FEVAR for Complex Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
Abdominal Aortic Aneurysm, Without Mention of Rupture
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 103
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 Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) 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 BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in FEVAR (fenestrated endovascular aortic repair) for complex aortic aneurysms.


Eligibility criteria: Inclusion Criteria:

* Patient eligible for elective repair of AAA/TAAA extent IV with FEVAR in accordance with the applicable guidelines for vascular interventions (Aneurysm size 5.5cm or aneurysm growth of \>5 mm within 6 months or 1 cm within 1 year).
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>55 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
* Patient has a projected life-expectancy of at least 12-months
* Indication of elective repair of AAA or TAAA with FEVAR in accordance with the applicable guidelines for vascular interventions
* Patient needs to have a landing zone in their target vessel of at least 10mm
* No early important division branch from the target vessel with risk of coverage
* Absence of dissection
* Target vessels (renal arteries, superior mesenteric artery and celiac trunk) should have a diameter between 5 and 10 mm
* Patient eligible for fenestrated endovascular repair as per IFU of the fenestrated endograft
* Angulation of the aorta at the level of the target vessels \<45 degrees
* The fenestrated endograft has to be constructed so the fenestrations lie in front of the orifice of the target vessel, and the gap between the fenestration and the orifice of the target vessel should not exceed 10mm.

Exclusion Criteria:

* Previously implanted endograft
* Patients refusing treatment
* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
* Patients with uncorrected bleeding disorders or heparin induced thrombozytopenia
* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
* Any planned surgical intervention/procedure within 30 days of the study procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
* Patients with diffuse distal disease resulting in poor stent outflow
* Fresh thrombus formation
* Stenosed (\>50%) or occluded target vessel
* Angulation between renal artery and aortic wall \<30 degrees
* Patients with known hypersensitivity to the stent material (L605) and/or PTFE
* Hybrid Approach
* Patients with a connective tissue disorder
* Patients with mycotic or inflammatory aneurysm
* Myocardial infarction or stroke within 3 months prior to the procedure
* Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
* Patients with ASA classification 5 or higher
* Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
* Patients with increased risk of intraoperative rupture
* 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 at 12 months
timeFrame: 12 months post-op
Secondary outcomes:
measure: Bridging stent patency post-procedure
timeFrame: 1 day post-op, 6-, 12, and 24- months post-op
measure: Freedom from bridging stent related endoleaks post-procedure
timeFrame: 1 day post-op, 6-, 12, and 24- months post-op
measure: Freedom from bridging stent related secondary intervention post-procedure
timeFrame: 1 day post-op, 6-, 12, and 24- months post-op
measure: Freedom from type I & III endoleaks 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 post-procedure
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 post-procedure
timeFrame: 1 day post-op, 6-, 12, and 24- months post-op
measure: Freedom from conversion to open surgical repair post-procedure
timeFrame: 1 day post-op, 6-, 12, and 24- months post-op
measure: Freedom from aneurysm related mortality post-procedure
timeFrame: 1 day post-op, 6-, 12, and 24- months post-op
measure: Freedom from aneurysm rupture within 12- and 24-months post-implantation
timeFrame: 12, and 24- months post-op
measure: Freedom from any major adverse events post-procedure
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: Aachen
country: Germany
facility: Alexander Gombert
city: Freiburg
country: Germany
facility: University Heart Center Freiburg- Bad Krozingen
city: Gießen
country: Germany
facility: University Hospital Gießen
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: München
country: Germany
facility: University Hospital LMU Munich
city: Münster
country: Germany
facility: Martin Austermann
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Stuttgart
country: Germany
facility: Hospital Stuttgart
Study officials:
affiliation: Foundation for Cardiovascular Research and Education
name: Eric Verhoeven, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: