N/A
N=40
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
Aortoiliac Aneurysms · Iliac Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT02571907 ↗Enrolled (actual)
40
Serious AEs
65.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms. — 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zenith® Branch Endovascular Graft-Iliac Bifurcation, (Device); Atrium iCAST™ (Device); Zenith® Flex AAA Endovascular Graft (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Research Incorporated
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms. |
39 | — |
| SECONDARY Freedom From Morbidity (i.e., Morbidity Index) |
34 | — |
Summary
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
Eligibility Criteria
Inclusion Criteria
- An aortioiliac or iliac aneurysm
- An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
Exclusion Criteria
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
- Unwilling or unable to comply with the follow-up schedule
- Simultaneously participating in another investigative device or drug study
Data sourced from ClinicalTrials.gov (NCT02571907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.