Back to resultsGORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms (TAMBE)
Primary Purpose
Thoracoabdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Thoracoabdominal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
- 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
- An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply
Exclusion Criteria:
- 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
- Renal Insufficiency Note: Additional Exclusion Criteria may apply
Sites / Locations
- Mayo Clinic
- Washington University School of Medicine
- Dartmouth-Hitchcock Medical Center
- The Mount Sinai Medical Center
- University of North Carolina Chapel Hill
- UPMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAMBE Device
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Technical Success, Including Individual Components of Technical Success
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
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)
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
Absence of Type I and Type III endoleaks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02528500
Brief Title
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
Acronym
TAMBE
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
February 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracoabdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAMBE Device
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Other Intervention Name(s)
TAMBE Device
Intervention Description
Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
Primary Outcome Measure Information:
Title
Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Description
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
Time Frame
Absence of procedural safety events through 30 days post procedure
Secondary Outcome Measure Information:
Title
Technical Success, Including Individual Components of Technical Success
Description
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
Time Frame
12-month
Title
Device Integrity, Including Individual Components of Device Integrity
Description
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
Time Frame
12-month
Title
Patency (Primary, Assisted Primary, and Secondary)
Description
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.
Time Frame
12-month
Title
Absence of Type I and Type III Endoleaks at One Month Follow-up
Description
Absence of Type I and Type III endoleaks
Time Frame
One Month followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply
Exclusion Criteria:
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
Renal Insufficiency Note: Additional Exclusion Criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Makaroun, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30612825
Citation
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.
Results Reference
derived
Learn more about this trial
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
We'll reach out to this number within 24 hrs