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: March 25, 2013
Last verified: March 2013
  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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01398332     History of Changes
Other Study ID Numbers: GRT 10-12
Study First Received: July 18, 2011
Last Updated: March 25, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 31, 2014