Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

B

Baptist Health South Florida

Status

Enrolling

Conditions

Aortic Arch Aneurysm
Thoracoabdominal Aortic Aneurysm

Treatments

Device: Zenith® t-Branch

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01524211
IDE G110081

Details and patient eligibility

About

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 aneurysms.

Full description

Study Update: As of 1/22/2024;174 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

225 participants in 1 patient group

Single Treatment Arm
Experimental group
Description:
All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.
Treatment:
Device: Zenith® t-Branch

Trial contacts and locations

0

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Central trial contact

Lisamarie Kernicky, RN;BSN;CCRC

Data sourced from clinicaltrials.gov

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