N/A
N=40
PRESERVE-Zenith® Iliac Branch System Clinical Study
Aorto-iliac Aneurysms · Iliac Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT01208415 ↗Enrolled (actual)
40
Serious AEs
17.5%
Results posted
Aug 2017
Primary outcome: Primary: Patients That Are Free From Patency-related Intervention — 33 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endovascular repair for aortoiliac or iliac aneurysms. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients That Are Free From Patency-related Intervention |
33 | — |
Summary
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.
Eligibility Criteria
Inclusion Criteria
- An aortoiliac or iliac aneurysm of appropriate size
- Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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
- Unsuitable arterial anatomy
Data sourced from ClinicalTrials.gov (NCT01208415). 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.