Clinical Trials Logo
  1. Home
  2. Aortic Aneurysm, Abdominal
  3. NCT00593814
  4. Details
NCT00593814 Clinical Trial

GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

Aortic Aneurysm, Abdominal Clinical Trial

Official title:
A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00593814
Other study ID # AAA 04-04
Secondary ID
Status Completed
Phase Phase 4
First received December 20, 2007
Last updated December 8, 2017
Start date June 2005
Est. completion date February 2009

Study information
Verified date December 2017
Source W.L.Gore & Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.

Recruitment information / eligibility
Status Completed
Enrollment 139
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter

2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use

3. Access vessel able to receive 18 French introducer sheath

4. Life expectancy > 2 years

5. Appropriate candidate for endovascular repair

6. Ability to comply with protocol requirements including follow-up

7. 21 years of age or older, male or infertile female**

Exclusion Criteria:

1. Mycotic or ruptured aneurysm

2. Participating in another investigational device or drug study within one year

3. Documented history of drug abuse within six months

4. Myocardial infarction or cerebral vascular accident within six weeks

5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function

6. Iliac anatomy that would require occlusion of both internal iliac arteries

7. Planned occlusion or reimplantation of significant mesenteric or renal arteries

8. Planned concomitant surgical procedure or previous major surgery within 30 days

9. Previous prosthesis placement in the aorta or iliac arteries

10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
Implant

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
W.L.Gore & Associates

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure 2 years
Secondary Number of Subjects With Device Efficacy Events 2 years
See also
  Status Clinical Trial Phase
Completed NCT03657979 - TAP-Block in Abdominal Aortic Surgery Phase 4
Enrolling by invitation NCT01465425 - Extracolonic Findings on Computed Tomography (CT) Colonography
Completed NCT02845167 - Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study N/A
Not yet recruiting NCT00358085 - NExT ERA: National Expertise Based Trial of Elective Repair of Abdominal Aortic Aneurysms: A Pilot Study Phase 3
Terminated NCT00118573 - Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair Phase 4
Completed NCT04792411 - Adherence and Acceptability of a Remote, Home-based, Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery N/A
Completed NCT04930172 - TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
Withdrawn NCT02995642 - Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation Phase 2
Completed NCT01980901 - Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
Active, not recruiting NCT01698671 - InterGard Synergy Post-Marketing Surveillance Study N/A
Enrolling by invitation NCT00831870 - EndoSure Sensor for Long-term Follow-up After Endovascular AAA Repair N/A
Recruiting NCT05972018 - Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters Phase 4
Not yet recruiting NCT02997618 - The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms N/A
Active, not recruiting NCT02907762 - Aorfix Intelliflex First in Human Study
Completed NCT00349947 - Exercise Therapy to Treat Adults With Abdominal Aortic Aneurysms Phase 1
Completed NCT04080557 - Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal
Recruiting NCT05484115 - Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck N/A
Recruiting NCT04503395 - ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES N/A
Completed NCT02867501 - Venous Distension in Patients With Aneurysmatic Arterial Disease N/A
Recruiting NCT02345590 - Eplerenone in the Management of Abdominal Aortic Aneurysms Phase 4