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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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;
    • 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).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Bernardo Mendes, M.D.

Abierto para la inscripción

Contact information:

Jessica Schneider

(507) 255-7249

Schneider.Jessica1@mayo.edu

More information

Publicaciones

Publications are currently not available