Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Zenith® t-Branch
- Terumo Arch Branch
Treatment groups
235 Participants
are divided into 2 treatment groupsSponsors and collaborators
Baptist Health South Florida
Lead sponsor
William Cook Australia
Collaborator
Bolton Medical
Collaborator
Source ClinicalTrials.gov