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Status:

RECRUITING

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Lead Sponsor:

Baptist Health South Florida

Collaborating Sponsors:

William Cook Australia

Bolton Medical

Conditions:

Thoracoabdominal Aortic Aneurysm

Aortic Arch Aneurysm

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic ane...

Detailed Description

Study Update as of 3/31/2025; 186 subjects successfully have been implanted with the Zenith t-Branch Device and 1 subject has been implanted with the Arch Branch to date and recruitment is ongoing.

Eligibility Criteria

Inclusion

  • Zenith t-Branch Eligibility Criteria:
  • Inclusion Criteria
  • The patient must have one of the following:
  • Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or
  • Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
  • Penetrating ulcers: ≥20mm in depth or
  • Chronic type B aortic dissections: ≥50mm total aortic diameter or
  • Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.
  • Additional criteria for LP material
  • • Iliofemoral access vessels \<8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator
  • Exclusion Criteria
  • General Criteria
  • Life-expectancy less than 12 months
  • Refusal to receive blood products
  • Age \<18 years
  • Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  • Unwilling to comply with the follow-up schedule
  • Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized
  • Medical Criteria
  • Uncontrolled systemic infection
  • Untreatable malignancy
  • Uncontrollable anaphylaxis to iodinated contrast
  • Known allergy(ies) to device materials
  • Anatomic Criteria
  • Any pathology of mycotic origin
  • Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
  • Inability to insert the Zenith® t-Branch device through iliofemoral approach
  • Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
  • Proximal landing zone length \<25mm to allow secure fixation and seal
  • Proximal landing zone diameter of \<24mm or \>42mm
  • Distal landing zone length \<25mm in the abdominal aorta or \<20mm in the iliac arteries
  • Distal landing zone diameter of \<14mm or \>30mm in the abdominal aorta, or \<7mm or \>28mm in the iliac arteries
  • Terumo Arch Branch Eligibility Criteria
  • Inclusion Criteria
  • The subject must have one of the following:
  • Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or \> 50 mm with a history of growth ≥5 mm in the last 6 months, or
  • Penetrating ulcers: ≥20 mm in depth, or
  • Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.
  • Age \>85 years old.
  • Prior median sternotomy (for any reason).
  • Prior open or endovascular thoracic aortic repair.
  • Severe aortic calcification.
  • Severe occlusive disease of one or more arch vessels.
  • Moderate-severe COPD (FEV1 \<80% predicted).
  • Severe CKD (Stage 3 or greater, eGFR \<60 mL/min).
  • LV dysfunction.
  • Chronic steroid or immunosuppressive use.
  • History of increased risk of bleeding.
  • Neurocognitive deficits that may significantly impact postoperative rehabilitation.
  • Musculoskeletal conditions that may significantly impact postoperative rehabilitation.
  • Exclusion Criteria
  • General Criteria
  • Life expectancy \<1 year.
  • Refusal to receive blood products.
  • Age \<18 years.
  • Pregnant, breastfeeding, or planning to become pregnant within 60 months.
  • Unwilling to comply with the follow-up schedule.
  • Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized.
  • Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution.
  • Medical Criteria
  • Pending cardiac surgery.
  • Untreatable severe, symptomatic coronary or valvular disease.
  • Prior mechanical aortic valve replacement (not bioprosthetic).
  • History of TAVR (Transcatheter Aortic Valve Replacement)
  • Severe, calcific aortic valvular stenosis.
  • Uncontrolled systemic infection.
  • Untreatable malignancy with \<1 year expected survival.
  • Uncontrollable anaphylaxis to iodinated contrast.
  • Known allergy(ies) to device materials. (i.e. polyester, nitinol).
  • Anatomic Criteria
  • Any pathology of mycotic origin.
  • Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).
  • Acute (\<2 weeks) aortic dissection.
  • Type A dissection.
  • Symptomatic or ruptured pathology.
  • Anatomy suitable for repair using commercially-available endograft.
  • Inability to insert the Arch Branch endograft through an iliofemoral approach.
  • Untreated, known extracranial carotid stenosis \>80%.
  • Ascending aortic angulation with radius of curvature \<15mm in the intended landing zone.
  • Proximal aortic landing zone length \<25 mm.
  • Proximal aortic landing zone diameter of \>43mm or \<28 mm.
  • Distal aortic landing zone diameter \<20 mm.
  • Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk \<70mm.
  • Target arch vessels:
  • Distal branch landing zone dimensions: I. Brachiocephalic trunk (innominate artery, BCT): Diameter \>24 mm or \<6 mm, length \<15 mm. ii. Common carotid artery: Diameter \<6 mm, length \<25mm. iii. Subclavian artery: Diameter \<6 mm, length \<25mm.

Exclusion

    Key Trial Info

    Start Date :

    January 25 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2032

    Estimated Enrollment :

    235 Patients enrolled

    Trial Details

    Trial ID

    NCT01524211

    Start Date

    January 25 2012

    End Date

    January 1 2032

    Last Update

    June 6 2025

    Active Locations (1)

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    Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)

    Boca Raton, Florida, United States, 33486