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Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

NCT ID: NCT01883999

Last Updated: 2021-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2021-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Common Iliac Artery Aneurysms Aorto-iliac Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GORE® EXCLUDER® Iliac Branch Endoprosthesis

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Group Type EXPERIMENTAL

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Intervention Type DEVICE

Interventions

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GORE® EXCLUDER® Iliac Branch Endoprosthesis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darren Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Schneider DB, Matsumura JS, Lee JT, Peterson BG, Chaer RA, Oderich GS. Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device. J Vasc Surg. 2023 Jan;77(1):122-128. doi: 10.1016/j.jvs.2022.07.006. Epub 2022 Jul 13.

Reference Type DERIVED
PMID: 35842202 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30064841 (View on PubMed)

Other Identifiers

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IBE 12-04

Identifier Type: -

Identifier Source: org_study_id