CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 351 enrolled
Drug / intervention
Thoraflex™ Hybriddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03735472
NCT03735472N/ACompleted

National Observational Study of the Thoraflex™ Hybrid Vascular Prosthesis in the Replacement of the Aortic Arch and the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta

Vascutek Ltd.·observational·Posted Nov 8, 2018·Updated Feb 19, 2025

In Brief

An observational study evaluating Thoraflex™ Hybrid for Aortic Arch; Aneurysm, Dissecting. Completed, enrolled 351 participants across 37 sites.

Detailed Summary

The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation to morbidity-mortality, visceral malperfusions, neurological and renal complications, endoleak and evolution of the aortic thoracic stent over time.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 8, 2018
Enrollment StartApr 1, 2016
Primary CompletionMay 1, 2019
Study CompletionNov 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.6 years ago

Interventions

Thoraflex™ Hybriddevice

The Thoraflex™ Hybrid device is particularly suited to the treatment of extended lesions of the ascending aorta, the aortic arch and the descending aorta, which constitute a major challenge in cardiovascular surgery. It enables, during a single surgical operation, combination of the "Frozen Elephant Trunk" technique and a 4-branch prosthesis of the aortic arch, thus enhancing the arsenal of the surgeon in the treatment of complex diseases of the aortic arch.