MDTEV20112009

About this trial

Last updated 11 years ago

Study ID

MDTEV20112009

Status

Terminated

Type

Observational

Placebo

Accepting

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 12 years ago

The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009. The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.

Inclusion Criteria

- Age ≥ 18 years or minimum age as required by local regulations

- Indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Valiant Captivia Thoracic Stent Graft System

- Signed consent form ('Patient informed consent form' or 'Patient Data Release Authorization Form')

- Intention to implant the Valiant Captivia Thoracic Stent Graft System or having implanted the system within the last 3 months before subject enrollment

- Willingness and ability to comply with the CIP

Exclusion Criteria

- High probability of non-adherence to physician's follow-up requirements

- Participation in concurrent interventional trial which may confound study results

- Prior implantation of a thoracic stent graft

VALIANT CAPTIVIA Post-market Registry