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Evaluation of the GORE® C3 Delivery System Module

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01398332
First received: July 18, 2011
Last updated: August 14, 2014
Last verified: August 2014

July 18, 2011
August 14, 2014
January 2011
November 2012   (final data collection date for primary outcome measure)
Evaluate procedural outcomes for the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System when used in accordance with the standard medical practice at each participating hospital. [ Time Frame: Up to 10 Years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01398332 on ClinicalTrials.gov Archive Site
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Evaluation of the GORE® C3 Delivery System Module
Global Registry for Endovascular Aortic Treatment(GREAT)

This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

This is a retrospective and prospective observational cohort Registry designed to obtain data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System. Patient and device performance outcomes will be collected during treatment and throughout all post-treatment visits, including follow-up extending up to 10 years.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients who undergo endovascular treatment for aortic pathologies with the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

Aortic Aneurysm, Abdominal
Device: Stent graft (EXCLUDER)
Endovascular repair
Other Name: EXCLUDER
Aortic pathologies
Indication for aortic endovascular stent graft repair
Intervention: Device: Stent graft (EXCLUDER)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
November 2022
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Minimum age required by local regulations (as applicable)
  2. Indication for aortic endovascular stent graft repair as determined by the treating physician (refer to current Instructions for Use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System)
Both
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No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01398332
GRT 10-12
Yes
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Eric Verhoeven, MD Klinikum Nürnberg-Süd
W.L.Gore & Associates
August 2014

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