VALIANT CAPTIVIA Post-market Registry (VCOUS)

This study has been terminated.
(CIP was amended to include long-term FU but, not all sites accepted it so the nr. of pts participating in the extended FU will be small.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01181947
First received: August 10, 2010
Last updated: July 3, 2013
Last verified: November 2012

August 10, 2010
July 3, 2013
February 2010
March 2013   (final data collection date for primary outcome measure)
Treatment success [ Time Frame: at 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ]

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.
Treatment success [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

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.
Complete list of historical versions of study NCT01181947 on ClinicalTrials.gov Archive Site
  • Technical success [ Time Frame: 0 days (assessed intraoperatively). ] [ Designated as safety issue: No ]
    Successful delivery and deployment of the stent graft (assessed intraoperatively).
  • SADE, SAE or TO [ Time Frame: through 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ]
    (Serious) Adverse Device Effects (SADE) Technical Observations (TO) Serious Adverse Events (SAE)
  • ACM and ARM [ Time Frame: at 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ]
    All-cause (ACM), Aneurysm related (ARM) and dissection related mortality
  • Technical success [ Time Frame: 0 days (assessed intraoperatively). ] [ Designated as safety issue: No ]
    Successful delivery and deployment of the stent graft (assessed intraoperatively).
  • SADE, SAE or TO [ Time Frame: through 12 months ] [ Designated as safety issue: Yes ]
    (Serious) Adverse Device Effects (SADE) Technical Observations (TO) Serious Adverse Events (SAE)
  • ACM and ARM [ Time Frame: 12 mo ] [ Designated as safety issue: Yes ]
    All-cause (ACM), Aneurysm related (ARM) and dissection related mortality
Not Provided
Not Provided
 
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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).

Aortic Aneurysm, Thoracic
Device: TEVAR
Thoracic endovascular aneurysm repair
Other Name: Valiant Captivia stent graft system
patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
Intervention: Device: TEVAR
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
August 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Italy,   Netherlands,   Spain,   Turkey,   United Kingdom
 
NCT01181947
MDTEV20112009
No
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Giovanni Torsello, Prof. St Franziskus Hospital GmbH
Principal Investigator: Rosella Fattori, Prof. Policlinico S.Orsola Malpighi
Principal Investigator: Carlos Vaquero Puerta, Dr. Hospital Clinico Universitario de Valladolid
Principal Investigator: Matthew Thompson, Prof. St. George's Hospital
Principal Investigator: Werner Jaschke, Prof. Medical University of Innsbruck
Principal Investigator: Yigit Goktay, Prof. Dokuz Eylül University
Principal Investigator: Karl Heinz Orend, Prof. Universitatsklinikum Ulm
Principal Investigator: Omke Teebken, Prof. Hannover Medical School
Principal Investigator: Thomas Schmitz-Rixen, Prof. Klinikum der J.W.Goethe-Universitat
Principal Investigator: Markus Steinbauer, Dr. Krankenhaus Barmherzige Bruder Regensburg
Principal Investigator: Stephan Zangos, Dr. Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
Principal Investigator: Joep Teijink, Dr. Catharina Ziekenhuis
Principal Investigator: Robin Heijmen, Dr. St. Antonius Ziekenhuis
Principal Investigator: Mustafa Parildar, Prof. Ege University Hospital
Principal Investigator: Fatih Boyvat, Prof. Baskent University Ankara Hospital
Medtronic Endovascular
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP