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A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

NCT01664078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-07-03

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Endovascular AAA repair with InCraft®

Sponsors & Collaborators

  • Carelon Research

    collaborator OTHER

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Michel S Makaroun, MD · University of Pittsburgh

  • Takao Ohki, MD · Jikei University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-10-31
Completion
2018-10-10

Countries

  • United States
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01664078 on ClinicalTrials.gov