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
  Purpose

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).


Condition Intervention Phase
Aortic Aneurysm, Abdominal
Device: Endurant Stent Graft System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Freedom from Aneurysm-related Mortality Rate (ARM) at 5 years (1826 days) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 178
Study Start Date: August 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379222

Locations
United States, Texas
Saint Luke's Episcopal Hospital-Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Medtronic Endovascular
Duke Clinical Research Institute
Investigators
Principal Investigator: Marc Schermerhorn, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01379222     History of Changes
Other Study ID Numbers: 10012289
Study First Received: June 21, 2011
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
AAA
Abdominal Aortic Aneurysm
EVAR

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 24, 2014