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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00875563
First received: February 19, 2009
Last updated: July 21, 2014
Last verified: July 2014

February 19, 2009
July 21, 2014
January 2005
April 2017   (final data collection date for primary outcome measure)
Treatment Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of vessels targeted by a fenestration intra-operatively), no type I or type III endoleaks, no AAA-related serious adverse events or major complications, and no aneurysm enlargement greater than 0.5 cm.
Treatment Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00875563 on ClinicalTrials.gov Archive Site
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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: 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
Endovascular Repair
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.
 
Active, not recruiting
67
April 2017
April 2017   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00875563
04-541, 370015, FNCT
Not Provided
Cook
Cook
Not Provided
Not Provided
Cook
July 2014

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