N/A N=42 Treatment

Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

Abdominal Aortic Aneurysms · Aorto-iliac Aneurysms · Juxtarenal Aneurysms

Bottom Line

View on ClinicalTrials.gov: NCT00875563 ↗

Enrolled (actual)

Serious AEs

9.5%

Results posted

Sep 2015

Primary outcome: Primary: Number of Participants With Treatment Success — 39 participants — p=0.02

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Zenith(R) Fenestrated AAA Endovascular Graft (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cook Group Incorporated
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Success	39	0.02 sig

Summary

The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

Eligibility Criteria

Inclusion Criteria

Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion Criteria

Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
Renal artery stenosis greater than 50 percent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00875563). 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.