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Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

NCT00345631 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2012-06-01

Study results available
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Summary

The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety.

Conditions

  • Angioplasty, Transluminal, Percutaneous Coronary
  • Coronary Arteriosclerosis
  • Peripheral Arteriosclerosis

Interventions

OTHER

Manual Compression

Manual compression

DEVICE

Vascular Closure Device

Investigational vascular closure device

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • S. Chiu Wong, MD · New York Presbyterian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Completion
2007-09-30

Countries

  • United States

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 NCT00345631 on ClinicalTrials.gov