Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Zenith Alpha™ Abdominal Endovascular Graft

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.
 
ClinicalTrials.gov Identifier: NCT03061825
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.

Condition or disease Intervention/treatment
Abdominal Aortic Aorto-iliac Aneurysm Device: Zenith Alpha™ Abdominal Endovascular Graft

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : January 6, 2021
Actual Study Completion Date : January 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: Zenith Alpha™ Abdominal Endovascular Graft
    Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Device Success [ Time Frame: 2 years ]
    Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase > 5 mm.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential study patients with abdominal aortic or aorto-iliac aneurysm will be "screened " at the hospital.
Criteria

Inclusion Criteria:

  • A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft

Exclusion Criteria:

  • Life expectancy less than (<) 2 years
  • Inability or refusal to give informed consent by the patient or legally authorized representative
  • Unwilling or unable to comply with the study follow-up
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061825


Locations
Layout table for location information
Canada, British Columbia
Vancouver Hospital and Health Science Center
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
Nova Soctia Health Authority
Halifax, Nova Scotia, Canada, B3H3A7
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
London Health Sciences Center
London, Ontario, Canada, N6A 4G5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 1X6
Sponsors and Collaborators
Cook Research Incorporated
Investigators
Layout table for investigator information
Principal Investigator: Thomas Forbes, MD Toronto General Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT03061825    
Other Study ID Numbers: 15-10
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases