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Trial record 1 of 1 for:    tambe 17-01
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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728985
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

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.
  • Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.

Condition or disease Intervention/treatment Phase
Thoracoabdominal Aortic Aneurysm Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study contains two single arm substudies. A primary study arm and a secondary study arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Primary Study Arm
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Endovascular Aortic Stent-Graft
Other Name: TAMBE

Experimental: Secondary Study Arm
TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)
Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Endovascular Aortic Stent-Graft
Other Name: TAMBE




Primary Outcome Measures :
  1. Percent of Subjects with Uncomplicated Technical Success and freedom from Procedural Safety Composite Event [ Time Frame: Index Procedure and Within 30 Days of Index Procedure ]

    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


  2. Percent of Subjects free from Clinically Significant Reintervention / Lesion-Related Mortality Co-Primary Endpoint Events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Percent of Subjects with Aneurysm-related mortality [ Time Frame: 30 days ]
  2. Percent of Subjects with Stented Segment Aortic Rupture [ Time Frame: 30 days ]
  3. Percent of Subjects with Lesion Related Mortality [ Time Frame: 30 days ]
  4. Percent of Subjects with Permanent Paraplegia [ Time Frame: 30 days ]
  5. Percent of Subjects with Permanent Paraparesis [ Time Frame: 30 days of index procedure ]
  6. Percent of Subjects with New Onset Renal Failure Requiring Dialysis [ Time Frame: 30 days ]
  7. Percent of Subjects with Severe Bowel Ischemia [ Time Frame: 30 days ]
  8. Percent of Subjects with Disabling Stroke [ Time Frame: 120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score) ]

    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

    1. No significant disability. Able to carry out all usual activities, despite some symptoms
    2. Slight Disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. Moderate Disability. Requires some help, but able to walk unassisted
    4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. Severe Disability. Requires constant nursing care and attention, bedridden, incontinent
    6. 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)


  9. Percent of Subjects with Access-Related Complications [ Time Frame: 30 days of index procedure ]
  10. Mean Procedural Blood Loss at Index Procedure [ Time Frame: Index Procedure ]
  11. Procedure Time [ Time Frame: Index Procedure ]
  12. Length of Hospital Stay [ Time Frame: 12 months ]
  13. Percent of Subjects with Extended Technical Clinical Success [ Time Frame: 30 days ]
    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.

  14. Percent of Subjects with Type I Endoleak [ Time Frame: 12 Months ]

    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.

  15. Percent of Subjects with Type II Endoleak [ Time Frame: 12 Months ]
    Endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch.

  16. Percent of Subjects with Type III Endoleak [ Time Frame: 12 Months ]

    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

  17. Percent of Subjects with Type IV Endoleak [ Time Frame: 12 Months ]

    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


  18. Percent of Subjects with Type IV Indeterminate Endoleak [ Time Frame: 12 Months ]

    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


  19. Percent of Subjects with Device Migration [ Time Frame: 12 Months ]
    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

  20. Percent of Subject with Thoracoabdominal Aneurysm (TAAA) Enlargement [ Time Frame: 12 Months ]
    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

  21. Percent of Subjects with Severe Distal Thromboembolic Events [ Time Frame: 12 Months ]
  22. Percent of Subjects with Aortic Rupture [ Time Frame: 12 Months ]
  23. Percent of Subjects with Device or procedure-related laparotomy [ Time Frame: 12 Months ]
  24. Percent of Subjects with Conversion to Open Repair [ Time Frame: 12 Months ]
  25. Percent of Subjects with Aortoiliac device limb occlusion [ Time Frame: 12 Months ]
  26. Percent of Subjects with Loss of device integrity [ Time Frame: 12 Months ]

    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

  27. Percent of Subjects with Reintervention [ Time Frame: 12 Months ]
    An additional unanticipated interventional or surgical procedure (including conversion to open surgery), related to the device (including withdrawal of the delivery system) or procedure.

  28. Percent of Subjects with Primary Patency [ Time Frame: 12 Months ]
    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)

  29. Percent of Subjects with Secondary Patency [ Time Frame: 12 Months ]
    Blood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass

  30. Percent of Subjects with Acute Kidney Injury [ Time Frame: 30 Days ]
    >50% decrease in eGFR within 30 day follow-up window of TAMBE Device treatment when compared to pre-treatment serum creatinine value.

  31. Percent of Subjects with Renal function deterioration [ Time Frame: 12 Months ]
    A sustained >25% decrease in eGFR over two consecutive study visits following TAMBE Device treatment when compared to pre-treatment serum creatinine value



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728985


Contacts
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Contact: Jennie Wurgler 800-437-8181 AAA1701@wlgore.com
Contact: Phillip Mckeown 800-437-8181 AAA1701@wlgore.com

Locations
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United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mark Farber, MD    919-966-3391    mark_farber@med.unc.edu   
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Mark Farber, MD University of North Carolina
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT03728985    
Other Study ID Numbers: AAA 17-01
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases