Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

NCT01883999 | Completed Results DMC

• 1 other identifier: IBE 12-04
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Common Iliac Artery Aneurysms; Aorto-iliac Aneurysms

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days post-treatment

• 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.

  Through 6 month follow-up visit

Secondary Outcomes (1)

• 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)

  Through 6 month follow-up visit

Study Arms (1)

GORE® EXCLUDER® Iliac Branch Endoprosthesis

EXPERIMENTAL

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis

Interventions

GORE® EXCLUDER® Iliac Branch Endoprosthesis DEVICE

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Related Publications (2)

• 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.

  PMID: 35842202 DERIVED

• 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.

  PMID: 30064841 DERIVED

Results Point of Contact

• Title: Abe Letter
• Organization: W.L. Gore & Associates

aletter@wlgore.com

928-864-3113

Study Officials

• Darren Schneider, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2021
• Last Updated: November 2, 2021
• Results First Posted: August 3, 2016

Record last verified: 2021-10

Locations

US (1)