Zenith(R) Low Profile AAA Endovascular Graft Clinical Study


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateMay 2015   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 4, 2009)		Composite rate of adverse clinical/device events [ Time Frame: during and after implantation ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: January 30, 2009)		Adverse events and device success. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Change HistoryComplete list of historical versions of study NCT00833924 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJEZenith(R) Low Profile AAA Endovascular Graft Clinical Study
Official Title  ICMJEEvaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Brief Summary

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

Detailed Description 
Study Phase 
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Open Label, Single Group Assignment
Condition  ICMJE
  • Abdominal Aortic Aneurysms
  • Iliac Aneurysms
  • Aorto-iliac Aneurysms
Intervention  ICMJEDevice: Zenith(R) Low Profile AAA Endovascular Graft
The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
Study Arms / Comparison Groups1
Treatment with Endovascular Graft
Intervention: Device: Zenith(R) Low Profile AAA Endovascular Graft

Recruitment Information

Estimated Enrollment  ICMJE120
Estimated Completion DateMay 2015
Estimated Primary Completion DateMay 2015   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
  • Vessels suitable for endovascular access and aneurysm repair

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Alison Conovaloff, MS765-463-7537aconovaloff@medinst.com
Location Countries  ICMJEUnited States,   Canada,   China,   Germany,   Russian Federation,   Sweden

Administrative Information

NCT ID  ICMJENCT00833924
Responsible PartyTheodore Heise, PhD, RAC, Vice President Regulatory Scientific Affairs, Cook Incorporated
Study ID Numbers  ICMJE08-013, 370016
Study Sponsor  ICMJECook
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Ronald Fairman, MDUniversity of Pennsylvania
Information Provided ByCook