A Study to Evaluate the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Overview

About this study

The purpose of this study is assess the safety and effectiveness of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprost (TAMBE) Device in the treatment of thoracoabdominal and pararenal aortic aneurysms.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • 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).
  • Aortic aneurysm includes most or all or the entire abdominal aorta, including the renal arteries with aneurysmal extension as far as 65 mm proximal to the celiac artery.
  • Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required).
  • Age ≥ 19 years at the time of informed consent signature.
  • Male or infertile female.
  • Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician.
  • Capable of complying with protocol requirements, including follow-up.
  • An Informed Consent Form signed by Subject or legal representative.
  • Sufficient distal landing zones in both iliac arteries to permit all EXCLUDER components to land proximal to the internal iliac bifurcation on each side.
  • 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:

  • 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.
  • The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery.
  • 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.
  • At least one patent internal iliac artery, without planned occlusion or embolization or the placement of a branched iliac device in order to achieve adequate distal seal concomitant with the TAMBE procedure.

Exclusion Criteria:

The patient is / has:

  • Prior open, aortic surgery of the ascending aorta or aortic arch.
  • Ruptured or leaking aortic aneurysm.
  • Aneurysmal dilatation due to chronic aortic dissection.
  • Infected aorta.
  • Mycotic aneurysm.
  • Life expectancy < 2 years.
  • Myocardial infarction or stroke within 1 year of treatment (staged or index procedure).
  • Systemic infection which may increase risk of endovascular graft infection.
  • Degenerative connective tissue disease; e.g. Marfan's or Ehler-Danlos Syndrome.
  • 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.
  • History of drug abuse; e.g., cocaine or amphetamine or alcohol, within 1 year of treatment.
  • Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access.
  • 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.
  • Known sensitivities or allergies to the device materials.
  • Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin.
  • Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta.
  • Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing dialysis).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bernardo Mendes, M.D.

Open for enrollment

Contact information:

Alisa Diderrich R.N.

(507) 538-8152

Diderrich.Alisa@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20463720

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