N/A
N=172
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00676494 ↗Enrolled (actual)
172
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Major Adverse Events (MAEs) Within 30 Days — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pathway PV Atherectomy System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pathway Medical Technologies Inc.
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Events (MAEs) Within 30 Days |
2 | — |
| SECONDARY Average Rutherford Classification Score at 6 Months |
1.5 | — |
| SECONDARY Average Ankle Brachial Index (ABI) at 6 Months |
0.77 | — |
| SECONDARY Freedom From Target Lesion Revascularization (TLR) at 6 Months |
147 | — |
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, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00676494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.