GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

NCT02528500 | Completed Results DMC

• 1 other identifier: AAA 13-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

Brief Summary

This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.

Conditions

Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL

  Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL

  Absence of procedural safety events through 30 days post procedure

Secondary Outcomes (4)

• Technical Success, Including Individual Components of Technical Success

  12-month

• Device Integrity, Including Individual Components of Device Integrity

  12-month

• Patency (Primary, Assisted Primary, and Secondary)

  12-month

• Absence of Type I and Type III Endoleaks at One Month Follow-up

  One Month followup

Study Arms (1)

TAMBE Device

EXPERIMENTAL

Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled.

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Interventions

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis DEVICE

Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Also known as: TAMBE Device

TAMBE Device

Eligibility Criteria

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

You may qualify if:

• Aortic aneurysm involving the visceral vessels requiring treatment
• Adequate access for TAMBE Device components
• Appropriate aortic anatomy to receive the TAMBE Device
• Age ≥ 18 years at the time of informed consent signature
• Male or infertile female
• The patient is considered high risk for open repair as deemed by the treating physician
• Capable of complying with protocol requirements, including follow-up

You may not qualify if:

• Prior aortic surgery
• Ruptured or leaking aortic aneurysm
• Aneurysmal dilatation due to chronic aortic dissection
• Infected aorta
• Mycotic aneurysm
• Life expectancy \<2 years
• Myocardial infarction or stroke within 6 weeks of treatment
• Systemic infection which may increase risk of endovascular graft infection
• Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• Participation in another drug or medical device study within 1 year of study enrollment
• History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
• Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
• Known sensitivities or allergies to the device materials
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
• Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (6)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Oderich GS, Farber MA, Silveira PG, Tadros R, Marin M, Fillinger M, Makaroun M, Hemmer J, Madden M. Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Aug;70(2):358-368.e6. doi: 10.1016/j.jvs.2018.10.103. Epub 2019 Jan 3.

  PMID: 30612825 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Rimma Zakharyan
• Organization: W. L. Gore & Associates

rzakhary@wlgore.com

928 310 6961

Study Officials

• Michel Makaroun, M.D.

  University of Pittsburgh

  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: August 17, 2015
• First Posted: August 19, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: February 1, 2023
• Last Updated: June 28, 2023
• Results First Posted: July 3, 2018

Record last verified: 2023-06

Locations

US (6)