BGP Stent as Bridging Stent in FEVAR

Marc Bosiers, MD

Status

Completed

Conditions

Abdominal Aortic Aneurysm, Without Mention of Rupture

Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Treatments

Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stent

Study type

Interventional

Funder types

Other

Identifiers

NCT03987035

FCRE-200504

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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