Aortic Aneurysm
Conditions
Brief summary
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.
Interventions
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.
Sponsors
NAMSA
Bentley InnoMed GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients with contraindications as listed in the IFUs * Previous stenting of the target vessel * Extension/relining of Bentley BSGs * Prior EVAR procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention | 12 months post index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related complications | during procedure, at discharge and 1 month and 12 months post index procedure | — |
| Bridging stent-related complications | during procedure, and 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| technical success defined as correct positioning and deployment of bridging stent grafts | during procedure | — |
| Primary patency rate defined as uninterrupted patency with no occlusion | 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| Secondary patency rate | 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| Freedom from secondary procedures | 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| Freedom from bridging stent related endoleaks | 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| Post-procedure Major adverse event rate | 1 month post procedure | — |
| Freedom from aneurysm-related death | 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| Freedom from aortic aneurysm maximum diameter increase | 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention | 1 month, 24 months, 36 months, 48 months, and 60 months post index procedure | — |
| Total procedure time | during procedure | — |
| total patient radiation dose | during procedure | — |
| total time of fluoroscopy | during procedure | — |
| total volume of received contrast medium | during procedure | — |
| Patient blood loss | during the procedure | — |
| duration of ICU stay | 1 month post index procedure | — |
| duration of total hospital stay | 1 month and 12 months post index procedure | — |
| mortality rate at 30 days | 1 month post index procedure | — |
| Quality of life score | 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure | EQ5D |
| Device implantation time | during procedure | — |
Contacts
Primary ContactRichard A Griesbach, Dr
Outcome results
None listed