Trials / Unknown
UnknownNCT04100499
Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR
Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Hospital Universitario Ramon y Cajal · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR. The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)
Detailed description
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed designed to improve the Endovascular aortic repair. This device is described to mimic an open surgical anastomosis during or after EVAR/TEVAR. The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type IA Endoleaks, migration and sac regression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ESAR (Endosutured Aneurysm Repair) | EndoAnchors adjunctive therapy for EVAR and TEVAR |
Timeline
- Start date
- 2019-12-31
- Primary completion
- 2020-12-31
- Completion
- 2022-11-19
- First posted
- 2019-09-24
- Last updated
- 2021-02-11
Locations
1 site across 1 country: Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04100499. Inclusion in this directory is not an endorsement.