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Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01379222
First received: June 21, 2011
Last updated: July 21, 2014
Last verified: July 2014

June 21, 2011
July 21, 2014
August 2011
August 2017   (final data collection date for primary outcome measure)
Freedom from Aneurysm-related Mortality Rate (ARM) at 5 years (1826 days) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01379222 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endurant Stent Graft System Post Approval Study
Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)

The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol.

The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm, Abdominal
Device: Endurant Stent Graft System
The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.
Not Provided
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
178
March 2018
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥18 years
  • Indication for elective surgical repair of AAA with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System
  • Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information
  • Intention to electively implant the Endurant Stent Graft System
  • Ability and willingness to comply with the CIP.

Exclusion Criteria:

  • High probability of non-adherence to physician's follow-up requirements
  • Current participation in a concurrent trial which may confound study results
  • Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01379222
10012289
No
Medtronic Endovascular
Medtronic Endovascular
Duke Clinical Research Institute
Principal Investigator: Marc Schermerhorn, MD Beth Israel Deaconess Medical Center
Medtronic Endovascular
July 2014

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