The (PIVOTAL) Study

Not Applicable

Terminated

• Conditions: ABDOMINAL AORTIC ANEURYSMS

• Registration Number: NCT00444821
• Lead Sponsor: Medtronic Cardiovascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-03-06
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2017-12-21
• Results First Submitted QC: 2018-03-23
• Results First Posted: 2018-04-23
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 728

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Experienced Rupture or Aneurysm Related Death	3 years

Secondary Outcome Measures

Name	Time	Method
Aneurysm Growth >0.5 cm	1 year	After repair, AAA enlargement by \>0.5cm
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up	study termination	secondary interventions in those that had successful delivery and deployment by treatment group randomized to.

Trial Locations

Locations (63)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Tucson Vascular Surgery; 🇺🇸 Tucson, Arizona, United States

University of Arizona - UMC; 🇺🇸 Tucson, Arizona, United States

VA Hospital; 🇺🇸 Little Rock, Arkansas, United States

Palomar Hospital; 🇺🇸 Escondido, California, United States

Long Beach VA Healthcare System; 🇺🇸 Long Beach, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Stanford University VA; 🇺🇸 Palo Alto, California, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

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