We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875563
First Posted: April 3, 2009
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
February 19, 2009
April 3, 2009
June 30, 2015
September 30, 2015
January 11, 2017
January 2005
February 2011   (Final data collection date for primary outcome measure)
Number of Participants With Treatment Success [ Time Frame: 6 months ]

Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm.

A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair.

A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.

Treatment Success [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00875563 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study
Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Abdominal Aortic Aneurysms
  • Aorto-iliac Aneurysms
  • Juxtarenal Aneurysms
Device: Zenith(R) Fenestrated AAA Endovascular Graft
The Zenith(R) Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
Experimental: 1
Zenith(R) Fenestrated AAA Endovascular Graft
Intervention: Device: Zenith(R) Fenestrated AAA Endovascular Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2015
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00875563
04-541
370015, FNCT
Not Provided
Not Provided
Not Provided
Cook Group Incorporated
Cook Group Incorporated
Not Provided
Not Provided
Cook Group Incorporated
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP