GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
Study summary
Prospective, non-randomized, , multicenter study with two independent arms:
* Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
* Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only
* Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.
Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following:
* Fusiform aneurysm diameter ≥ 5 cm
* Saccular aneurysm (no diameter requirement)
* Rapid aneurysm growth (≥ 5 mm in one year)
2. Aortic aneurysm that involves the abdominal aorta, with:
* Involvement of at least one visceral vessel and aneurysmal extension as far as 65 mm proximal to the celiac artery, and/or
* No normal aorta between the upper extent of aneurysm and renal artery(s)
3. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required)
4. Age ≥ 19 years at the time of informed consent signature
5. Male or infertile female
6. Patient assessment favors an endovascular approach when compared to open surgical 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
9. Sufficient distal landing zones in both iliac arteries, with at least one patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery.
10. Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:
* For the TAMBE aortic component, proximal aortic landing zone diameters between 22-34 mm
* Proximal seal zone ≥ 20 mm in length
* Aortic neck angle ≤ 60°
* Distal landing zone (iliac arteries) 8-25 mm
* Distal seal zone in iliac arteries of at least 10 mm in length
* Renal artery landing zone diameters between 4-10 mm
* Celiac and superior mesenteric artery landing zone diameters between 5-12 mm
* ≥ 15 mm landing zone in each branch vessel
* Landing zones in the proximal and distal aorta and all branch vessels cannot be aneurysmal, heavily calcified, or heavily thrombosed
* Patent left subclavian artery
Secondary Study Arm Only:
11. If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a CTAG Device is required. The aortic landing zone diameter treatment range with the CTAG Device is 19.5-32 mm
12. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery.
13. The most proximal aortic device seal zone will be within native aorta or a previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another device manufacturer's stent graft will not be supported
Exclusion Criteria:
The patient is / has:
1. Prior open, aortic surgery of the ascending aorta or aortic arch
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 1 year of treatment (staged or index procedure)
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 an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening
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. A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow
14. Known sensitivities or allergies to the device materials
15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
16. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
17. Renal Insufficiency (creatinine value \> 1.8 mg/dL, GFR \< 30, or patient undergoing dialysis)
18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment
Primary outcome measure(s)
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event — From start of Index Procedure to 59 Days Post Procedure Percent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event.
Device Technical Success Composite Events during Index Procedure:
Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal
Procedural Safety during 30 days of Index Procedure:
Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabling Stroke
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality — 12 Months Composite Outcome of Lesions-Related Mortality and Clinically Significant Reinterventions through 12 Months for Pre-defined Reasons.
Trial sites (44)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Mayo Clinic Arizona
Scottsdale
Arizona
Keck Medical Center of USC
Los Angeles
California
Cedars-Sinai Medical Center
Los Angeles
California
Kaiser Permanente San Francisco Medical Center
San Francisco
California
Stanford University
Stanford
California
MedStar Health Research Institute - MedStar Washington Hospital
Washington D.C.
District of Columbia
University of Florida - Gainesville
Gainesville
Florida
University of South Florida
Tampa
Florida
Emory University Hospital
Atlanta
Georgia
Northwestern University
Chicago
Illinois
Indiana University
Indianapolis
Indiana
University of Maryland Medical Center
Baltimore
Maryland
Massachusetts General Hospital
Boston
Massachusetts
University of Michigan - Cardiac Surgery
Ann Arbor
Michigan
Essentia Health
Duluth
Minnesota
Division of Vascular Surgery - Minneapolis Heart Institute
Minneapolis
Minnesota
Mayo Clinic - Rochester
Rochester
Minnesota
Washington University School of Medicine
St Louis
Missouri
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
Mount Sinai West
New York
New York
Weill Cornell Medical Center
New York
New York
University of Rochester
Rochester
New York
University of North Carolina
Chapel Hill
North Carolina
Sanger Heart & Vascular Institute
Charlotte
North Carolina
Duke University Medical Center
Durham
North Carolina
Cleveland Clinic
Cleveland
Ohio
The Ohio State University Wexner Medical Center
Columbus
Ohio
University of Pennsylvania
Philadelphia
Pennsylvania
UPP Heart and Vascular Institute
Pittsburgh
Pennsylvania
University of Tennessee -University Vascular Surgeons
Knoxville
Tennessee
St. David's Healthcare
Austin
Texas
Baylor Heart & Vascular Hospital
Dallas
Texas
University of Texas Southwestern
Dallas
Texas
Baylor College of Medicine
Houston
Texas
The Methodist Hospital - Houston
Houston
Texas
University of Texas Health Science Center
Houston
Texas
Sentara Medical Group
Norfolk
Virginia
Carilion Clinic Hospitals
Roanoke
Virginia
University of Washington
Seattle
Washington
+ 4 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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