Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 aneurysms. Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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

∙ 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.

Locations
United States
Florida
Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
RECRUITING
Boca Raton
Contact Information
Primary
Lisamarie Kernicky, RN;BSN;CCRC
lkernicky@brrh.com
561-955-5239
Time Frame
Start Date: 2012-01-25
Estimated Completion Date: 2032-01
Participants
Target number of participants: 235
Treatments
Experimental: Single Treatment Arm-Zenith t-Branch Cohort
Zenith t-Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.
Experimental: Single Treatment Arm-Terumo Arch Branch Cohort
Terumo Arch Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Terumo Arch Branch Endovascular Graft.
Related Therapeutic Areas
Sponsors
Collaborators: Bolton Medical, William Cook Australia
Leads: Baptist Health South Florida

This content was sourced from clinicaltrials.gov