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Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Primary Purpose

Common Iliac Artery Aneurysms, Aorto-iliac Aneurysms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GORE® EXCLUDER® Iliac Branch Endoprosthesis

About this trial

This is an interventional treatment trial for Common Iliac Artery Aneurysms

Eligibility Criteria

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

Inclusion Criteria:

Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
An Informed Consent Form signed by Subject or legally authorized representative
Male or infertile female
Able to comply with protocol requirements including following-up
Life expectancy > 2 years
Age > 21 years
Surgical candidate

Exclusion Criteria:

Mycotic or ruptured aneurysm
Known concomitant thoracic aortic aneurysm which requires intervention
American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
Renal insufficiency defined or patient undergoing dialysis
New York Heart Association (NYHA) Functional Classification class IV
Dissected, heavily calcified, or heavily thrombosed landing zone(s)
Tortuous or stenotic iliac and/or femoral arteries
Participating in another investigational device or drug study within 1 year of treatment
Systemic infection which may increase the risk of endovascular graft infection
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
Planned concomitant surgical procedure or major surgery within 30 days of treatment date
Known history of drug abuse
Known sensitivities or allergies to the device materials

Sites / Locations

Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Arm Description

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Outcomes

Primary Outcome Measures

Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair

Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.

Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC

Freedom from all of the following: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC). Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.

Secondary Outcome Measures

Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)

Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).

Full Information

NCT ID

NCT01883999

First Posted

June 18, 2013

Last Updated

October 22, 2021

Sponsor

W.L.Gore & Associates

1. Study Identification

Unique Protocol Identification Number

NCT01883999

Brief Title

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Official Title

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

October 2013 (Actual)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

W.L.Gore & Associates

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).

6. Conditions and Keywords

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

Common Iliac Artery Aneurysms, Aorto-iliac Aneurysms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Arm Type

Experimental

Arm Description

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Intervention Type

Device

Intervention Name(s)

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Primary Outcome Measure Information:

Title

Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair

Description

Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.

Time Frame

30 days post-treatment

Title

Description

Time Frame

Through 6 month follow-up visit

Secondary Outcome Measure Information:

Title

Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)

Description

Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).

Time Frame

Through 6 month follow-up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Common iliac aneurysm with or without concomitant abdominal aortic aneurysm Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses An Informed Consent Form signed by Subject or legally authorized representative Male or infertile female Able to comply with protocol requirements including following-up Life expectancy > 2 years Age > 21 years Surgical candidate Exclusion Criteria: Mycotic or ruptured aneurysm Known concomitant thoracic aortic aneurysm which requires intervention American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation) Renal insufficiency defined or patient undergoing dialysis New York Heart Association (NYHA) Functional Classification class IV Dissected, heavily calcified, or heavily thrombosed landing zone(s) Tortuous or stenotic iliac and/or femoral arteries Participating in another investigational device or drug study within 1 year of treatment Systemic infection which may increase the risk of endovascular graft infection Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome Planned concomitant surgical procedure or major surgery within 30 days of treatment date Known history of drug abuse Known sensitivities or allergies to the device materials

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Darren Schneider, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30064841

Citation

Schneider DB, Milner R, Heyligers JMM, Chakfe N, Matsumura J. Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings. J Vasc Surg. 2019 Feb;69(2):367-377.e1. doi: 10.1016/j.jvs.2018.05.200. Epub 2018 Jul 29.

Results Reference

derived

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Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

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