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The (PIVOTAL) Study

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: NCT00444821
Recruitment Status : Terminated (Interim analysis of Primary Endpoint completed)
First Posted : March 8, 2007
Results First Posted : April 23, 2018
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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Brief Summary:
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.

Condition or disease Intervention/treatment Phase
ABDOMINAL AORTIC ANEURYSMS Device: AneuRx AAA stent graft / Talent AAA stent graft Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 728 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Study Start Date : March 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Surveillance
Experimental: Early Endovascular Repair Device: AneuRx AAA stent graft / Talent AAA stent graft
Catheter based stent graft inserted to seal off an abdominal aortic aneurysm


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects That Experienced Rupture or Aneurysm Related Death [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Aneurysm Growth >0.5 cm [ Time Frame: 1 year ]
    After repair, AAA enlargement by >0.5cm

  2. Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up [ Time Frame: study termination ]
    secondary interventions in those that had successful delivery and deployment by treatment group randomized to.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 to 90 years of age
  • Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
  • Maximum aneurysm diameter of 4-5cm
  • If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion
  • Patient is willing and able to comply with the specified follow-up evaluation
  • Life expectancy at least 3 years

Exclusion Criteria:

  • Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use
  • Known co-existing condition with a life expectancy of less than 3 years
  • Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment
  • Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.
  • Planned conduit procedure for introduction of endograft
Contacts and Locations
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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): NCT00444821


Locations
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Sponsors and Collaborators
Medtronic Cardiovascular
The Cleveland Clinic
Investigators
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Principal Investigator: Kenneth Ouriel, MD New York Presbyterian Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT00444821    
Other Study ID Numbers: VS-2005-01
First Posted: March 8, 2007    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: October 11, 2021
Last Verified: October 2021
Keywords provided by Medtronic Cardiovascular:
AAA
Aneurysm
AneuRx
Talent
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases