BGP+ Stent as Bridging Stent in BEVAR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

BGP Stent as Bridging Stent in FEVAR

NCT03987035

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

COMPLETED NA

Bentley Bridging Stent Graft Study

NCT07295145

Aortic Aneurysm

NOT_YET_RECRUITING

Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease

NCT05805111

Aorto-iliac Occlusive Disease

RECRUITING

Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System

NCT04023370

Iliac Artery Stenosis

ACTIVE_NOT_RECRUITING NA

Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System

NCT02211716

Peripheral Vascular Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

BGP+ Stent Graft System as bridging stent

Intervention Type DEVICE

BGP+ Stent Graft System as bridging stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BGP+ Stent Graft System as bridging stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No