The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676494
• Other study ID #: PTC 05003
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: May 18, 2009
• Start date: February 2006
• Est. completion date: February 2008

Study information

• Verified date: May 2009
• Source: Pathway Medical Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: February 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Pathway PV Atherectomy System
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pathway Medical Technologies Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events (MAEs) Within 30 Days		30 days	Yes
Secondary	Average Rutherford Classification Score at 6 Months		6 months	No
Secondary	Average Ankle Brachial Index (ABI) at 6 Months		6 months	No
Secondary	Freedom From Target Lesion Revascularization (TLR) at 6 Months		6 months	No