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The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

NCT00612924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2017-10-16

Study results available
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Summary

The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System

Conditions

  • Infrarenal Abdominal Aortic Aneurysm

Interventions

DEVICE

Anaconda Stent Graft System

Endovascular device

DEVICE

Anaconda ONE-LOK Stent Graft System

Endovascular device

Sponsors & Collaborators

  • Vascutek Ltd.

    collaborator INDUSTRY

  • Terumo CVS

    lead INDUSTRY

Principal Investigators

  • Steven Pregulman, MD · Terumo Cardiovascular Systems Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-07-31
Completion
2017-07-13

Countries

  • United States
  • Canada

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 NCT00612924 on ClinicalTrials.gov