Health TrialsbyHealthPanel

Bentley Bridging Stent Graft Study

ConditionAortic Aneurysm
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBentley InnoMed GmbH

About this trial

This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects for the use as bridging stent grafts in combination with fenestrated aortic endovascular grafts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients having complex abdominal aortic aneurysms suitable for an endovascular repair with a fenestrated and/or branched aortic endovascular graft in combination with one Bentley bridging stent graft per reno-visceral artery in accordance with the IFU of BeFlared, BeGraft or BeGraft Plus. Use of different products for different target vessels is allowed. Use of stents from other manufacturers for other reno-visceral arteries is allowed.

Patient is capable and willing to sign the informed consent and agrees to fulfil follow-up requirements

Patients ≥18 years of age at the time of consent

Disqualifiers

Patients with contraindications as listed in the IFUs

Previous stenting of the target vessel

Extension/relining of Bentley BSGs

Prior EVAR procedure

Trial population

Adult patients having complex abdominal aortic aneurysms

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • endovascular aortic repair (EVAR)

    Device

    The primary goal of EVAR is to bypass the aneurysm sac with the aortic endovascular graft. Through isolation of the aneurysm sac, the blood pressure on the affected aortic tissue is reduced. This prevents aneurysm growth, which is otherwise associated with an elevated risk of rupture. As the pressure on the aneurysm sac is minimized, the current risk of rupture is also mitigated. In case that arteries branch off from the aorta in the area of the aneurysm, or at the proximal and distal sealing zones of the endograft, complex EVAR approaches are employed, which include stenting of the aortic branches (mostly renal and visceral arteries, also called target vessels) in addition to implantation of an aortic endovascular graft. A distinction is made between different variants of complex EVAR procedures, which comprise fenestrated endovascular aneurysm repair (FEVAR), branched endovascular aneurysm repair (BEVAR) and hybrid approaches.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention

Time frame
12 months post index procedure

Secondary outcomes

1

Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention

Time frame
1 month, 24 months, 36 months, 48 months, and 60 months post index procedure
2

Procedure-related complications

Time frame
during procedure, at discharge and 1 month and 12 months post index procedure
3

Bridging stent-related complications

Time frame
during procedure, and 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
4

technical success defined as correct positioning and deployment of bridging stent grafts

Time frame
during procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bentley InnoMed GmbH

Lead sponsor

NAMSA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: