The (PIVOTAL) Study

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

The (PIVOTAL) Study

Official Title

Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)

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.

Study Type

Interventional

Primary Outcome

Number of Subjects That Experienced Rupture or Aneurysm Related Death

Secondary Outcome

 Aneurysm Growth >0.5 cm

Condition

ABDOMINAL AORTIC ANEURYSMS

Intervention

AneuRx AAA stent graft / Talent AAA stent graft

Study Arms / Comparison Groups

 Surveillance
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

728

Start Date

March 2005

Completion Date

January 2010

Primary Completion Date

January 2010

Eligibility 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

Gender

All

Ages

40 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Kenneth Ouriel, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00444821

Organization ID

VS-2005-01

Responsible Party

Sponsor

Study Sponsor

Medtronic Cardiovascular

Collaborators

 The Cleveland Clinic

Study Sponsor

Kenneth Ouriel, MD, Principal Investigator, New York Presbyterian Hospital

Verification Date

October 2021