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
  Purpose

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.


Condition Intervention
Aortic Aneurysm, Thoracic
Device: TEVAR

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: August 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
Device: TEVAR
Thoracic endovascular aneurysm repair
Other Name: Valiant Captivia stent graft system

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181947

Locations
Austria
Medical University of Innsbruck
Innsbruck, Austria, 6020
Germany
Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
Frankfurt am Main, Germany, D-60590
Klinikum der J.W.Goethe-Universitat
Frankfurt am Main, Germany, D-60590
Medizinische Hochschule Hannover
Hannover, Germany, 30625
St Franziskus Hospital GmbH
Muenster, Germany, 48145
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, Germany, 93049
Universitatsklinikum Ulm
Ulm, Germany, D-89075
Italy
Polyclinic Hospital S.Orsola - Malpighi
Bologna, Italy, 40138
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435EM
Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain, 47005
Turkey
Baskent University Ankara Hospital
Ankara, Turkey, 06490
Ege University Hospital
Izmir, Turkey
Dokuz Eylul University
Izmir, Turkey
United Kingdom
St George`s Hospital
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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
  More Information

No publications provided by Medtronic Endovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01181947     History of Changes
Other Study ID Numbers: MDTEV20112009
Study First Received: August 10, 2010
Last Updated: July 3, 2013
Health Authority: Austrian: Ethics Commision
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee

Keywords provided by Medtronic Endovascular:
Stent graft
thoracic aorta
dissection
aneurysm
TEVAR
VALIANT
CAPTIVIA
endovascular

Additional relevant MeSH terms:
Aortic Aneurysm
Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on September 16, 2014