Clinical trial NCT03728985: Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Official title: Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysm
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study contains two single arm substudies. A primary study arm and a secondary study arm.
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
timeFrame: From start of Index Procedure to 59 Days Post Procedure
measure: Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
timeFrame: 12 Months
Secondary outcomes:
measure: Percent of Subjects With Aneurysm-related Mortality
timeFrame: 30 days
measure: Percent of Subjects With Stented Segment Aortic Rupture
timeFrame: 30 days
measure: Percent of Subjects With Lesion Related Mortality
timeFrame: 30 days
measure: Percent of Subjects With Permanent Paraplegia
timeFrame: 30 days
measure: Percent of Subjects With Permanent Paraparesis
timeFrame: 30 days of index procedure
measure: Percent of Subjects With New Onset Renal Failure Requiring Dialysis
timeFrame: 30 days
measure: Percent of Subjects With Severe Bowel Ischemia
timeFrame: 30 days
measure: Percent of Subjects With Disabling Stroke
timeFrame: 120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score)
measure: Percent of Subjects With Access-Related Complications
timeFrame: 30 days of index procedure
measure: Mean Procedural Blood Loss at Index Procedure
timeFrame: Index Procedure
measure: Procedure Time
timeFrame: Index Procedure
measure: Length of Hospital Stay
timeFrame: 12 months
measure: Percent of Subjects With Extended Technical Clinical Success
timeFrame: 30 days
measure: Percent of Subjects With Type I Endoleak
timeFrame: 12 Months
measure: Percent of Subjects With Type II Endoleak
timeFrame: 12 Months
measure: Percent of Subjects With Type III Endoleak
timeFrame: 12 Months
measure: Percent of Subjects With Type IV Endoleak
timeFrame: 12 Months
measure: Percent of Subjects With Type IV Indeterminate Endoleak
timeFrame: 12 Months
measure: Percent of Subjects With Device Migration
timeFrame: 12 Months
measure: Percent of Subject With Thoracoabdominal Aneurysm (TAAA) Enlargement
timeFrame: 12 Months
measure: Percent of Subjects With Severe Distal Thromboembolic Events
timeFrame: 12 Months
measure: Percent of Subjects With Aortic Rupture
timeFrame: 12 Months
measure: Percent of Subjects With Device or Procedure-related Laparotomy
timeFrame: 12 Months
measure: Percent of Subjects With Conversion to Open Repair
timeFrame: 12 Months
measure: Percent of Subjects With Aortoiliac Device Limb Occlusion
timeFrame: 12 Months
measure: Percent of Subjects With Loss of Device Integrity
timeFrame: 12 Months
measure: Percent of Subjects With Reintervention
timeFrame: 12 Months
measure: Percent of Subjects With Primary Patency
timeFrame: 12 Months
measure: Percent of Subjects With Secondary Patency
timeFrame: 12 Months
measure: Percent of Subjects With Acute Kidney Injury
timeFrame: 30 Days
measure: Percent of Subjects With Renal Function Deterioration
timeFrame: 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute - MedStar Washington Hospital
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida - Gainesville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - Cardiac Surgery
state: Michigan
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Minneapolis
country: United States
facility: Division of Vascular Surgery - Minneapolis Heart Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPP Heart and Vascular Institute
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee -University Vascular Surgeons
state: Tennessee
city: Austin
country: United States
facility: St. David's Healthcare
state: Texas
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital - Houston
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Hospitals
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Health Care, Metro Inc.
state: Wisconsin
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: St. Mary's Hospital, Imperial College Healthcare, NHS Trust
Study officials:
affiliation: University of North Carolina
name: Mark Farber, MD
role: PRINCIPAL_INVESTIGATOR
References: