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A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System

NCT00911417 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-09-05

No results posted yet for this study

Summary

The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood clots removed by the Jetstream System.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Disease

Interventions

DEVICE

Pathway Jetstream Atherectomy System

The Pathway Jetstream System is a commercially available rotating, aspirating, expandable catheter for active removal of plaque and blood clots in peripheral arteries of the lower limbs.

Sponsors & Collaborators

  • Pathway Medical Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Tom Davis, MD · St. John's Hospital and Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-07-31
Completion
2011-08-31

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 NCT00911417 on ClinicalTrials.gov