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

Not Applicable

Completed

• Conditions: Thoracoabdominal Aortic Aneurysm

• Registration Number: NCT02528500
• Lead Sponsor: W.L.Gore & Associates

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.

Detailed Description

This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.

Study Timeline

• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Study Start: 2015-11
• Primary Completion: 2016-05
• Results First Submitted: 2018-06-04
• Results First Submitted QC: 2018-06-04
• Results First Posted: 2018-07-03
• Study Completion: 2023-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Aortic aneurysm involving the visceral vessels requiring treatment
2. Adequate access for TAMBE Device components
3. Appropriate aortic anatomy to receive the TAMBE Device
4. Age ≥ 18 years at the time of informed consent signature
5. Male or infertile female
6. The patient is considered high risk for open repair as deemed by the treating physician
7. Capable of complying with protocol requirements, including follow-up
8. An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 procedural safety events through 30 days post procedure	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

Secondary Outcome Measures

Name	Time	Method
Patency (Primary, Assisted Primary, and Secondary)	12-month	Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.
Absence of Type I and Type III Endoleaks at One Month Follow-up	One Month followup	Absence of Type I and Type III endoleaks
Technical Success, Including Individual Components of Technical Success	12-month	Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure
Device Integrity, Including Individual Components of Device Integrity	12-month	Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components

Trial Locations

Locations (6)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

The Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States