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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00911417
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : September 5, 2011
Sponsor:
Information provided by (Responsible Party):
Pathway Medical Technologies Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Peripheral Vascular Disease Device: Pathway Jetstream Atherectomy System Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study
Study Start Date : June 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

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Arms and Interventions
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Plaque Morphology [ Time Frame: up to 12 month follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is ≥ 18 years of age.
  • The documented peripheral vascular disease is/are located in a superficial femoral, popliteal or tibial peroneal trunk arteries in the lower limb.
  • The patient is an acceptable candidate for percutaneous intervention using the Jetstream G2 System in accordance with its labeled indications and instructions for use.
  • The patient has been informed about the nature of the study and has provided informed consent.

Exclusion Criteria:

  • Patient has no distal runoff.
  • Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
  • Patient is pregnant or nursing a child.
  • Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G2 System.
  • Patient has clinically significant abnormal ECG or blood test results or any other factor that would put the patient at increased risk if participating in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911417


Locations
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United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
St. Luke's Hospital
Phoenix, Arizona, United States, 85006
United States, Illinois
St. John's Hospital
Springfield, Illinois, United States, 62701
United States, Michigan
St. John Hospital & Medical Ctr.
Detroit, Michigan, United States, 48236
United States, New York
Mount Sinai Medical Center
New York City, New York, United States, 10029
Sponsors and Collaborators
Pathway Medical Technologies Inc.
Investigators
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Principal Investigator: Tom Davis, MD St. John's Hospital and Medical Center
More Information
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Responsible Party: Pathway Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT00911417    
Other Study ID Numbers: PTC09030
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011
Keywords provided by Pathway Medical Technologies Inc.:
peripheral arterial disease
peripheral vascular disease
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases