Back to resultsA Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
Primary Purpose
Peripheral Arterial Disease, Peripheral Vascular Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pathway Jetstream Atherectomy System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, peripheral vascular disease
Eligibility 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.
Sites / Locations
- Arizona Heart Institute
- St. Luke's Hospital
- St. John's Hospital
- St. John Hospital & Medical Ctr.
- Mount Sinai Medical Center
Outcomes
Primary Outcome Measures
Plaque Morphology
Secondary Outcome Measures
Full Information
NCT ID
NCT00911417
First Posted
May 19, 2009
Last Updated
September 2, 2011
Sponsor
Pathway Medical Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00911417
Brief Title
A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
Official Title
The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pathway Medical Technologies Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Peripheral Vascular Disease
Keywords
peripheral arterial disease, peripheral vascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pathway Jetstream Atherectomy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque Morphology
Time Frame
up to 12 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Davis, MD
Organizational Affiliation
St. John's Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
St. Luke's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
St. John Hospital & Medical Ctr.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York City
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
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