The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

Not Applicable

Completed

• Conditions: Peripheral Artery Disease

• Registration Number: NCT00676494
• Lead Sponsor: Pathway Medical Technologies Inc.

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-07
• Study Completion: 2008-02
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Results First Submitted: 2009-02-23
• Status Verified: 2009-05
• Results First Submitted QC: 2009-05-18
• Last Update Submitted: 2009-05-18
• Results First Posted: 2009-07-09
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major Adverse Events (MAEs) Within 30 Days	30 days	Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.

Secondary Outcome Measures

Name	Time	Method
Average Rutherford Classification Score at 6 Months	6 months	Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)
Average Ankle Brachial Index (ABI) at 6 Months	6 months	Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)
Freedom From Target Lesion Revascularization (TLR) at 6 Months	6 months	Number of patients that did not require target lesion revascularization 6 months after index procedure.