Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Thoracoabdominal Aortic Aneurysm Clinical Trial

— TAMBE  

Official title:

Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03728985
• Other study ID #: AAA 17-01
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: September 2026

Study information

• Verified date: January 2024
• Source: W.L.Gore & Associates
• Contact: Sarah Rosbach
• Phone: 800-437-8181
• Email: AAA1701[@]wlgore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Thoracoabdominal Aortic Aneurysm

Intervention

Device:
• GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Endovascular Aortic Stent-Graft

Locations

Country	Name	City	State
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London
United Kingdom	St. Mary's Hospital, Imperial College Healthcare, NHS Trust	London
United States	University of Michigan - Cardiac Surgery	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Cardiothoracic and Vascular Surgeons, PA (CTVS)	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Sanger Heart & Vascular Institute	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Heart & Vascular Hospital	Dallas	Texas
United States	University of Texas Southwestern	Dallas	Texas
United States	Essentia Health	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	The Methodist Hospital - Houston	Houston	Texas
United States	University of Texas Health Science Center	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Tennessee -University Vascular Surgeons	Knoxville	Tennessee
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Aurora Health Care, Metro Inc.	Milwaukee	Wisconsin
United States	Division of Vascular Surgery - Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Mount Sinai West	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Sentara Medical Group	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	UPP Heart and Vascular Institute	Pittsburgh	Pennsylvania
United States	Carilion Clinic Hospitals	Roanoke	Virginia
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Kaiser Permanente San Francisco Medical Center	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California
United States	University of South Florida	Tampa	Florida
United States	MedStar Health Research Institute - MedStar Washington Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Subjects with Uncomplicated Technical Success and freedom from Procedural Safety Composite Event	Percent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event.; Device Technical Success Composite Events: Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal; Procedural Safety: Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabling Stroke	Index Procedure and Within 30 Days of Index Procedure
Primary	Percent of Subjects free from Clinically Significant Reintervention / Lesion-Related Mortality Co-Primary Endpoint Events		12 months
Secondary	Percent of Subjects with Aneurysm-related mortality		30 days
Secondary	Percent of Subjects with Stented Segment Aortic Rupture		30 days
Secondary	Percent of Subjects with Lesion Related Mortality		30 days
Secondary	Percent of Subjects with Permanent Paraplegia		30 days
Secondary	Percent of Subjects with Permanent Paraparesis		30 days of index procedure
Secondary	Percent of Subjects with New Onset Renal Failure Requiring Dialysis		30 days
Secondary	Percent of Subjects with Severe Bowel Ischemia		30 days
Secondary	Percent of Subjects with Disabling Stroke	Stroke will be assessed using the Modified Rankin Scale. Stroke identified as having occurred within 30 days of the index endovascular procedure, combined with mRS =2 with an increase from baseline of at least one grade at 90 days.; Modified Rankin Scale: 0 - No Symptoms; No significant disability. Able to carry out all usual activities, despite some symptoms; Slight Disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate Disability. Requires some help, but able to walk unassisted; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe Disability. Requires constant nursing care and attention, bedridden, incontinent; Dead; Higher Values are worse. A total score will not be computed, but a change from baseline will be calculated as (90 Day Post-Stroke MRS Score - Baseline MRS Score)	120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score)
Secondary	Percent of Subjects with Access-Related Complications		30 days of index procedure
Secondary	Mean Procedural Blood Loss at Index Procedure		Index Procedure
Secondary	Procedure Time		Index Procedure
Secondary	Length of Hospital Stay		12 months
Secondary	Percent of Subjects with Extended Technical Clinical Success	Patients who present within the 30-Day follow-up with no Type I or Type III endoleak, as evaluated by CTA, and free from device-related intervention.	30 days
Secondary	Percent of Subjects with Type I Endoleak	Endoleak arising from the proximal or distal sealing zone of a device perfusing the aneurysm; Type IA: Inadequate seal at the proximal end of the device placed in the aorta; Type IB: Inadequate seal at the distal end of the device placed in iliac vessel; Type IC: Inadequate seal at the distal end of a device placed inside branch vessel Reported as ratio with the number of subjects with Type I Endoleak as numerator, number of subjects with an evaluable result as denominator. Ratios of Type IA, IB, and IC will also be reported.	12 Months
Secondary	Percent of Subjects with Type II Endoleak	Endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch.	12 Months
Secondary	Percent of Subjects with Type III Endoleak	Type III Endoleak through 12 months - Endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material perfusing the aneurysm.; Type III General: A Type III endoleak whose source cannot be differentiated between an intercomponent junction or graft tear; Type IIIA: Modular disconnection or apposition failure; Type IIIB: Graft tear	12 Months
Secondary	Percent of Subjects with Type IV Endoleak	Endoleak of whole blood through the graft fabric perfusing the aneurysm; Reported as a ratio. Numerator: Number of Subjects with Type IV Endoleak. Denominator: Number of Subjects with an Evaluable Result	12 Months
Secondary	Percent of Subjects with Type IV Indeterminate Endoleak	Endoleak perfusing the aneurysm without a definitive source; Reported as a ratio. Numerator: Number of Subjects with Type IV Endoleak. Denominator: Number of Subjects with an Evaluable Result	12 Months
Secondary	Percent of Subjects with Device Migration	Longitudinal movement of all or part of the device for a distance =10 mm, as confirmed by CT scan, relative to anatomical landmarks and device positioning at the first post-operative CT scan	12 Months
Secondary	Percent of Subject with Thoracoabdominal Aneurysm (TAAA) Enlargement	An increase in the maximum aneurysm diameter of 5 mm or more relative to the first post-operative CT scan within the 30 day follow-up window	12 Months
Secondary	Percent of Subjects with Severe Distal Thromboembolic Events		12 Months
Secondary	Percent of Subjects with Aortic Rupture		12 Months
Secondary	Percent of Subjects with Device or procedure-related laparotomy		12 Months
Secondary	Percent of Subjects with Conversion to Open Repair		12 Months
Secondary	Percent of Subjects with Aortoiliac device limb occlusion		12 Months
Secondary	Percent of Subjects with Loss of device integrity	Defined as any of the following: Wire fracture identified in the sealing row stents of either the aortic, branch or iliac components; Transient (compression) or permanent stent-graft collapse (invagination) following complete device deployment, resulting in an overall reduction in the aortic, branch or iliac vessel luminal diameter	12 Months
Secondary	Percent of Subjects with Reintervention	An additional unanticipated interventional or surgical procedure (including conversion to open surgery), related to the device (including withdrawal of the delivery system) or procedure.	12 Months
Secondary	Percent of Subjects with Primary Patency	Blood flow without occlusion maintained through the device after implant without an intervention. Assisted Primary Patency through 12 Months- Blood flow maintained through the device after implant regardless of re-interventions performed (without occlusion)	12 Months
Secondary	Percent of Subjects with Secondary Patency	Blood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass	12 Months
Secondary	Percent of Subjects with Acute Kidney Injury	>50% decrease in eGFR within 30 day follow-up window of TAMBE Device treatment when compared to pre-treatment serum creatinine value.	30 Days
Secondary	Percent of Subjects with Renal function deterioration	A sustained >25% decrease in eGFR over two consecutive study visits following TAMBE Device treatment when compared to pre-treatment serum creatinine value	12 Months