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Evaluation of the GORE® C3 Delivery System Module

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
W.L.Gore & Associates Identifier:
First received: July 18, 2011
Last updated: December 29, 2016
Last verified: December 2016
This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

Condition Intervention
Aortic Aneurysm, Abdominal
Device: Stent graft (EXCLUDER)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global Registry for Endovascular Aortic Treatment(GREAT)

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • 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 ]

Enrollment: 400
Study Start Date: January 2011
Estimated Study Completion Date: November 2022
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aortic pathologies
Indication for aortic endovascular stent graft repair
Device: Stent graft (EXCLUDER)
Endovascular repair
Other Name: EXCLUDER

Detailed Description:
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo endovascular treatment for aortic pathologies with the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01398332

Klinikum Nürnberg-Süd
Nurnberg, Germany, 90471
Sponsors and Collaborators
W.L.Gore & Associates
Principal Investigator: Eric Verhoeven, MD Klinikum Nürnberg-Süd
  More Information

Responsible Party: W.L.Gore & Associates Identifier: NCT01398332     History of Changes
Other Study ID Numbers: GRT 10-12
Study First Received: July 18, 2011
Last Updated: December 29, 2016

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on May 25, 2017