NCT01398332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

13.5 years

First QC Date

July 18, 2011

Last Update Submit

July 30, 2024

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (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.

    Up to 10 Years

Study Arms (1)

Aortic pathologies

Indication for aortic endovascular stent graft repair

Device: Stent graft (EXCLUDER)

Interventions

Stent graft (EXCLUDER)DEVICE

Endovascular repair

Also known as: EXCLUDER
Aortic pathologies

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Minimum age required by local regulations (as applicable)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Nürnberg-Süd

Nuremberg, 90471, Germany

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Eric Verhoeven, MD

    Klinikum Nürnberg-Süd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations

DE(1)