VALIANT CAPTIVIA Post-market Registry

Aortic Aneurysm, Thoracic Clinical Trial

— VCOUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01181947
• Other study ID #: MDTEV20112009
• Status: Terminated
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: January 2023
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic

Intervention

Device:
• TEVAR
Thoracic endovascular aneurysm repair

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Germany	Klinikum der J.W.Goethe-Universitat	Frankfurt am Main
Germany	Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie	Frankfurt am Main
Germany	Medizinische Hochschule Hannover	Hannover
Germany	St Franziskus Hospital GmbH	Muenster
Germany	Krankenhaus Barmherzige Bruder Regensburg	Regensburg
Germany	Universitatsklinikum Ulm	Ulm
Italy	Polyclinic Hospital S.Orsola - Malpighi	Bologna
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Turkey	Baskent University Ankara Hospital	Ankara
Turkey	Dokuz Eylul University	Izmir
Turkey	Ege University Hospital	Izmir
United Kingdom	St George's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Netherlands,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	SAE	Serious Adverse Events (SAE)	through 12 months
Secondary	ACM and ARM	All-cause (ACM), Aneurysm related (ARM) and dissection related mortality	at 30 days, 12 months, 24 months and 36 months