VALIANT CAPTIVIA Post-market Registry

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Use of controls 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 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. Number of investigation sites and study duration 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects. There will be no minimum nor maximum number of enrolled subjects per investigation site. 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.

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

Conditions
-----------------
Aortic Aneurysm, Thoracic

Intervention / Treatment
-----------------
* Device: TEVAR


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients undergoing TEVAR<br>Those with a thoracic aortic aneurysm/dissection | Device: TEVAR<br>* Thoracic endovascular aneurysm repair<br>* Other names: Valiant Captivia stent graft system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success | technical success and freedom from TAA diameter increase of stented segment (>5mm compared to 1 mo), Types I/III endoleak, Aneurysm rupture, Conversion to open surgery, Stent graft occlusion, Stent graft migration resulting in SAE or secondary intervention. | at 12 months | 
| Technical Success at Time of Initial Implant | Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAE | Serious Adverse Events (SAE) | through 12 months | 
| ACM and ARM | All-cause (ACM), Aneurysm related (ARM) and dissection related mortality | at 30 days, 12 months, 24 months and 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stent graft, thoracic aorta, dissection, aneurysm, TEVAR, VALIANT, CAPTIVIA, endovascular