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

• ClinicalTrials.gov Identifier: NCT02528500
• Recruitment Status: Completed
• First Posted: August 19, 2015
• Results First Posted: July 3, 2018
• Last Update Posted: June 28, 2023
• Sponsor: W.L.Gore & Associates
• Information provided by (Responsible Party): W.L.Gore & Associates

Tracking Information

• First Submitted Date: August 17, 2015
• First Posted Date: August 19, 2015
• Results First Submitted Date: June 4, 2018
• Results First Posted Date: July 3, 2018
• Last Update Posted Date: June 28, 2023
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2018)

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

• Original Primary Outcome Measures (submitted: August 17, 2015): Absence of the following procedural safety events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL [ Time Frame: Absence of procedural safety events through 30 days post procedure ]

Current Secondary Outcome Measures (submitted: June 7, 2023)

• Technical Success, Including Individual Components of Technical Success [ Time Frame: 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 [ Time Frame: 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
• Patency (Primary, Assisted Primary, and Secondary) [ Time Frame: 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 [ Time Frame: One Month followup ]
  Absence of Type I and Type III endoleaks

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
• Official Title: Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Thoracoabdominal Aortic Aneurysm

Intervention

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

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

Other Name: TAMBE Device

Study Arms

Experimental: TAMBE Device

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.

Intervention: Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 17, 2015): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2023
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02528500
• Other Study ID Numbers: AAA 13-02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: W.L.Gore & Associates
• Original Responsible Party: Same as current
• Current Study Sponsor: W.L.Gore & Associates
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michel Makaroun, M.D.; University of Pittsburgh

• PRS Account: W.L.Gore & Associates
• Verification Date: June 2023