Clinical trial NCT01181947: VALIANT CAPTIVIA Post-market Registry
Official title: VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Aneurysm, Thoracic
Keywords: Stent graft
thoracic aorta
dissection
aneurysm
TEVAR
VALIANT
CAPTIVIA
endovascular
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Valiant Thoracic Stent Graft with the Captivia Delivery System is indicated for treatment of diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The Valiant Thoracic Stent Graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture and restoration of blood flow through the stent graft lumen. The device is intended for use in subjects who are candidates for conventional surgical repair, and in subjects who are not candidates for conventional surgical repair due to pre-existing risk factors.

Study enrolment is open to subjects who in the opinion of the investigator are candidates for endovascular TAA repair with the Valiant Captivia Thoracic Stent Graft System according to the instructions for use (IFU).

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: 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.

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

Primary outcomes:
measure: Treatment Success
timeFrame: at 12 months
measure: Technical Success at Time of Initial Implant
timeFrame: intraoperatively
Secondary outcomes:
measure: SAE
timeFrame: through 12 months
measure: ACM and ARM
timeFrame: at 30 days, 12 months, 24 months and 36 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Frankfurt am Main
country: Germany
facility: Klinikum der J.W.Goethe-Universitat
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Muenster
country: Germany
facility: St Franziskus Hospital GmbH
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder Regensburg
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Bologna
country: Italy
facility: Polyclinic Hospital S.Orsola - Malpighi
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University
city: Izmir
country: Turkey
facility: Ege University Hospital
city: London
country: United Kingdom
facility: St George's Hospital
Study officials:
affiliation: St Franziskus Hospital GmbH
name: Giovanni Torsello, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico S.Orsola Malpighi
name: Rosella Fattori, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario de Valladolid
name: Carlos Vaquero Puerta, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. George's Hospital
name: Matthew Thompson, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Innsbruck
name: Werner Jaschke, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Yigit Goktay, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitatsklinikum Ulm
name: Karl Heinz Orend, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Omke Teebken, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum der J.W.Goethe-Universitat
name: Thomas Schmitz-Rixen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Krankenhaus Barmherzige Bruder Regensburg
name: Markus Steinbauer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
name: Stephan Zangos, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis
name: Joep Teijink, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Robin Heijmen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Hospital
name: Mustafa Parildar, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Baskent University Ankara Hospital
name: Fatih Boyvat, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heijmen RH, Thompson MM, Fattori R, Goktay Y, Teebken OE, Orend KH. Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry. J Endovasc Ther. 2012 Apr;19(2):213-25. doi: 10.1583/11-3652MR.1.