Clinical Trial Details

NCT ID: NCT01524211
Date Last Changed: November 13, 2014

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Zenith® t-Branch for the treatment of Thoracoabdominal Aortic Aneurysm

Research Study Title

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Purpose

The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system for the treatment of aortic aneurysms.

To Learn more

Recruitment Details

Phase
2
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Lee, W. Anthony, M.D. FACS
Duration
48 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

Subject must have one of the following:

  1. Degenerative, atherosclerotic thoracoabdominal aortic aneurysm (fusiform or saccular): ≥55mm in diameter or

  2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year.

  3. Penetrating ulcers: ≥20mm in depth or

  4. Chronic type B aortic dissections: ≥55mm total aortic diameter or

  5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size

Exclusion Criteria:

  1. Life-expectancy less than 12 months

  2. Refusal to receive blood products

  3. Age < 18 years

  4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months

  5. Unwilling to comply with the follow-up schedule

  6. Inability or refusal to give informed consent

Medical Exclusion Criteria

  1. Uncontrolled systemic infection

  2. Untreatable malignancy

  3. Heart Attack(MI) or stroke in last 90 days

  4. Unstable/Ruptured aneurysm

  5. Uncontrollable anaphylaxis to iodinated contrast

  6. Known allergy(ies) to device materials

  7. History of chronic abdominal pain

  8. Coagulopathy or any bleeding disorder

  9. Contraindication to general anesthesia

Anatomic Exclusion Criteria

  1. Any pathology of mycotic origin

  2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)

  3. Extensive thrombus or calcifications in the aortic arch

  4. Excessive tortuosity precluding safe passage of the Zenith® t-Branch or its components

  5. Inability to insert the Zenith® t-Branch device through iliofemoral approach

  6. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm

  7. Proximal landing zone length < 25mm to allow secure fixation and seal

  8. Proximal landing zone diameter of < 24mm or > 38mm

  9. Distal landing zone length < 25mm in the abdominal aorta or < 20mm in the iliac arteries

  10. Distal landing zone diameter of < 24mm or > 30mm in the abdominal aorta, or < 7mm or

20mm in the iliac arteries

Site Locations (1)

Country State City Zip Facility and Contact
United States Florida Boca Raton 33486 Boca Raton Regional Hospital (BRRH)
Lisamarie Kernicky, RN;BSN;CCRC
561-955-5239
lkernicky@brrh.com

Contact

Lisamarie Kernicky, RN;BSN;CCRC
561-955-5239
E-mail:

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