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Evaluation of the GORE® C3 Delivery System Module

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ClinicalTrials.gov Identifier: NCT01398332
Recruitment Status : Active, not recruiting
First Posted : July 20, 2011
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

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

Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Device: Stent graft (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.

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global Registry for Endovascular Aortic Treatment(GREAT)
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : November 2022

Group/Cohort Intervention/treatment
Aortic pathologies
Indication for aortic endovascular stent graft repair
Device: Stent graft (EXCLUDER)
Endovascular repair
Other Name: EXCLUDER




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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)

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

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01398332     History of Changes
Other Study ID Numbers: GRT 10-12
First Posted: July 20, 2011    Key Record Dates
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