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Trial record 10 of 78 for:    zenith

Zenith® Low Profile AAA 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: NCT02535065
Recruitment Status : Active, not recruiting
First Posted : August 28, 2015
Results First Posted : June 6, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief Summary:
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysms Iliac Aneurysms Aortoiliac Aneurysms Device: Zenith Low Profile AAA Endovascular Graft and ancillary components Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
Study Start Date : August 2014
Actual Primary Completion Date : January 23, 2017
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Endovascular Graft
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Device: Zenith Low Profile AAA Endovascular Graft and ancillary components
Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair




Primary Outcome Measures :
  1. Number of Patients Without Major Adverse Events [ Time Frame: 30 days ]
    Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation

  2. Number of Patients With Technical Success [ Time Frame: 12 months ]
    Technical success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has at least one of the following

    • Aortic or aortoiliac aneurysm
    • Iliac aneurysm
    • Aneurysm with a history of growth

Exclusion Criteria:

  • Less than 18 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Pregnant of breastfeeding or planning on becoming pregnant with 60 months
  • Unwilling to comply with the follow-up schedule

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): NCT02535065


Locations
Show Show 37 study locations
Sponsors and Collaborators
Cook Research Incorporated
  Study Documents (Full-Text)

Documents provided by Cook Group Incorporated ( Cook Research Incorporated ):

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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT02535065    
Other Study ID Numbers: 08-013 Spiral-Z
First Posted: August 28, 2015    Key Record Dates
Results First Posted: June 6, 2018
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Low Profile
Abdominal Aortic Aneurysms
Endovascular
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases