A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study
1 other identifier
interventional
40
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2009
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedSeptember 5, 2011
September 1, 2011
2.1 years
May 19, 2009
September 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plaque Morphology
up to 12 month follow-up
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
St. Luke's Hospital
Phoenix, Arizona, 85006, United States
St. John's Hospital
Springfield, Illinois, 62701, United States
St. John Hospital & Medical Ctr.
Detroit, Michigan, 48236, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Davis, MD
St. John's Hospital and Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2009
First Posted
June 1, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
September 5, 2011
Record last verified: 2011-09