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Evaluation of the GORE® C3 Delivery System Module

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01398332
First Posted: July 20, 2011
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
W.L.Gore & Associates
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398332


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

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01398332     History of Changes
Other Study ID Numbers: GRT 10-12
First Submitted: July 18, 2011
First Posted: July 20, 2011
Last Update Posted: September 8, 2017
Last Verified: September 2017

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