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Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
31 mm GORE EXCLUDER® AAA Endoprosthesis
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infrarenal AAA > or equal to 4.5 cm in diameter
  • Proximal infrarenal aortic neck length > or equal 15mm
  • Anatomy meets 31mm EXCLUDER specification criteria
  • Access vessel able to receive 20 Fr. introducer sheath
  • Life expectancy >2 years
  • Surgical candidate
  • ASA Class I, II, III, or IV
  • NYHA Class I, II, III
  • 21 years of age or older
  • Male or infertile female
  • Ability to comply with protocol requirements including follow-up
  • Signed Informed Consent Form

Exclusion Criteria:

  • Mycotic or ruptured aneurysm
  • Participating in another investigational device or drug study within 1 year
  • Documented history of drug abuse within 6 months
  • Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
  • Myocardial infarction or cerebral vascular accident within 6 weeks
  • Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
  • Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis
  • Iliac anatomy that would require occlusion of both internal iliac arteries
  • "Planned" occlusion or reimplantation of significant mesenteric or renal arteries
  • "Planned" concomitant surgical procedure or previous major surgery within 30 days
  • Previous prosthesis placement in the same position of the aorta or iliac arteries
  • Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
  • Proximal neck angulation > 60 degrees
  • Presence of significant thrombus at arterial implantation sites

Sites / Locations

  • St. Vincent Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

31 mm GORE EXCLUDER® Test Subjects

Arm Description

GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)

Outcomes

Primary Outcome Measures

Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year

Secondary Outcome Measures

Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications

Full Information

First Posted
December 20, 2007
Last Updated
March 23, 2015
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00615069
Brief Title
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
Official Title
A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
Detailed Description
The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
31 mm GORE EXCLUDER® Test Subjects
Arm Type
Experimental
Arm Description
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
Intervention Type
Device
Intervention Name(s)
31 mm GORE EXCLUDER® AAA Endoprosthesis
Other Intervention Name(s)
GORE EXCLUDER® Bifurcated Endoprosthesis
Intervention Description
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
Primary Outcome Measure Information:
Title
Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
Time Frame
Treatment through 1 year post-procedure (365 days)
Secondary Outcome Measure Information:
Title
Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications
Time Frame
Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infrarenal AAA > or equal to 4.5 cm in diameter Proximal infrarenal aortic neck length > or equal 15mm Anatomy meets 31mm EXCLUDER specification criteria Access vessel able to receive 20 Fr. introducer sheath Life expectancy >2 years Surgical candidate ASA Class I, II, III, or IV NYHA Class I, II, III 21 years of age or older Male or infertile female Ability to comply with protocol requirements including follow-up Signed Informed Consent Form Exclusion Criteria: Mycotic or ruptured aneurysm Participating in another investigational device or drug study within 1 year Documented history of drug abuse within 6 months Coexisting thoracic aortic aneurysm (50% larger than proximal aorta) Myocardial infarction or cerebral vascular accident within 6 weeks Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis Iliac anatomy that would require occlusion of both internal iliac arteries "Planned" occlusion or reimplantation of significant mesenteric or renal arteries "Planned" concomitant surgical procedure or previous major surgery within 30 days Previous prosthesis placement in the same position of the aorta or iliac arteries Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome Proximal neck angulation > 60 degrees Presence of significant thrombus at arterial implantation sites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon S Matsumura, M.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States

12. IPD Sharing Statement

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Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

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