Status:
COMPLETED
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
Lead Sponsor:
Pathway Medical Technologies Inc.
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature. This is a prospective, single arm...
Eligibility Criteria
Inclusion
- Documented symptomatic atherosclerotic peripheral vascular disease
- Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
- The patient has been informed of the nature of the study and has provided informed consent
- The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits
Exclusion
- Target lesion is located in the iliac artery.
- Target lesion stenosis is \< 70%.
- Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- Patient is unable to participate for the duration of the study.
- Patient is currently participating or has participated in a study with another investigational medical device or medication.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00676494
Start Date
February 1 2006
End Date
February 1 2008
Last Update
July 9 2009
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