Status:
COMPLETED
A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
Lead Sponsor:
Pathway Medical Technologies Inc.
Conditions:
Peripheral Arterial Disease
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00911417
Start Date
June 1 2009
End Date
August 1 2011
Last Update
September 5 2011
Active Locations (5)
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1
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
2
St. Luke's Hospital
Phoenix, Arizona, United States, 85006
3
St. John's Hospital
Springfield, Illinois, United States, 62701
4
St. John Hospital & Medical Ctr.
Detroit, Michigan, United States, 48236