The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Pathway PV Atherectomy System

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events (MAEs) Within 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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Rutherford Classification Score at 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)	6 months
Average Ankle Brachial Index (ABI) at 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)	6 months
Freedom From Target Lesion Revascularization (TLR) at 6 Months	Number of patients that did not require target lesion revascularization 6 months after index procedure.	6 months

Collaborators and Investigators

• Sponsor: Pathway Medical Technologies Inc.
• Investigators: Principal Investigator: Thomas Zeller, MD, Herz Zentrum Bad Krozingen, Germany

Publications and helpful links

General Publications

• Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, Bosiers M, Peeters P, Balzer JO, Gray W, Tubler T, Wissgott C, Schwarzwalder U, Scheinert D. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62. doi: 10.1583/09-2826.1.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: May 8, 2008
• First Submitted That Met QC Criteria: May 12, 2008
• First Posted (Estimate): May 13, 2008

Study Record Updates

• Last Update Posted (Estimate): July 9, 2009
• Last Update Submitted That Met QC Criteria: May 18, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: PTC 05003