VALIANT CAPTIVIA Post-market Registry

VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study

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.

1. Use of controls

   1. This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned.

      Sample size

   2. There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months.

2. Number of investigation sites and study duration

   1. 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
   2. There will be no minimum nor maximum number of enrolled subjects per investigation site.
   3. The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.

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