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Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/dissection of the Descending Thoracic Aorta

NCT03735472 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 351

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

  • Aortic Arch; Aneurysm, Dissecting

Interventions

DEVICE

Thoraflex™ Hybrid

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.

Sponsors & Collaborators

  • Vascutek Ltd.

    lead INDUSTRY

Principal Investigators

  • Professor Thierry Caus · Centre Hospitalier Universitaire. Heart, Chest and Vascular Centre, AMIENS

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-05-31
Completion
2024-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03735472 on ClinicalTrials.gov