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

Thoracoabdominal Aortic Aneurysm Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528500
• Other study ID #: AAA 13-02
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 2023

Study information

• Verified date: June 2023
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• 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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

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