---
title: "Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best"
nct_id: NCT06187051
overall_status: COMPLETED
sponsor: University Paul Sabatier of Toulouse
study_type: OBSERVATIONAL
primary_condition: Aorta Aneurysm
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06187051.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06187051"
ct_last_update_post_date: 2024-01-10
last_seen_at: "2026-05-12T06:24:04.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best

**Official Title:** FEVAR or Open Repair to Treat Type 1 Endoleak : A French Multicentric Study

**NCT ID:** [NCT06187051](https://clinicaltrials.gov/study/NCT06187051)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** University Paul Sabatier of Toulouse
- **Conditions:** Aorta Aneurysm
- **Start Date:** 2010-01-01
- **Completion Date:** 2023-12-01
- **CT.gov Last Update:** 2024-01-10

## Brief Summary

Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation.

A retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Type 1A endoleak after EVAR

Exclusion Criteria:

* no
```

## Arms

- **Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR**
- **Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR**

## Interventions

- **FEVAR** (DEVICE) — Relining the EVAR with FEVAR
- **Explantation** (DEVICE) — open surgery to explant the previous EVAR

## Primary Outcomes

- **Post operative mortality** _(time frame: day 30 post operative)_ — Patient death after the treatment of type 1A endoleak
- **Major adverse cardiovascular event (MACE) post operative** _(time frame: day 30 post operative)_ — Patient presenting after surgery a composite score (MACE) including

* nonfatal stroke,
* nonfatal myocardial infarction
* cardiovascular death
- **Redo surgery after type 1A endoleak surgery** _(time frame: 30 day, 6 months, 12 months, 24 months)_ — Reintervention after FEVAR or explantation surgery

## Secondary Outcomes

- **Efficiency of the treatment** _(time frame: 30 day, 6 months, 12 months, 24 months)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06187051.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06187051*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*