Thoracoabdominal Aortic Aneurysm Clinical Trial
— TAMBEOfficial 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
NCT number | NCT02528500 |
Other study ID # | AAA 13-02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | February 2023 |
Verified date | June 2023 |
Source | W.L.Gore & Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 2023 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina Chapel Hill | Chapel Hill | North Carolina |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | The Mount Sinai Medical Center | New York | New York |
United States | UPMC | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 12-month | |
Secondary | 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 | 12-month | |
Secondary | 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. | 12-month | |
Secondary | Absence of Type I and Type III Endoleaks at One Month Follow-up | Absence of Type I and Type III endoleaks | One Month followup |
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