The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

NCT ID: NCT00676494

Last Updated: 2009-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-02-29

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pathway Medical Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Pathway Medical Technologies Inc.

Principal Investigators

Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

Herz Zentrum Bad Krozingen, Germany

Dierk Scheinert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

References

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.

Reference Type: DERIVED

PMID: 19995118 (View on PubMed)

Other Identifiers

PTC 05003

Identifier Type: -

Identifier Source: org_study_id