NCT00676494

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 9, 2009

Completed
Last Updated

July 9, 2009

Status Verified

May 1, 2009

Enrollment Period

1.4 years

First QC Date

May 8, 2008

Results QC Date

February 23, 2009

Last Update Submit

May 18, 2009

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Average Rutherford Classification Score at 6 Months

    6 months

  • Average Ankle Brachial Index (ABI) at 6 Months

    6 months

  • Freedom From Target Lesion Revascularization (TLR) at 6 Months

    6 months

Interventions

Pathway PV Atherectomy SystemDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19995118DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Kevin Peters/Director of Clinical Affairs
Organization
Pathway Medical Technologies, Inc.
petersk@pathwaymedical.com
425-636-4053

Study Officials

  • Thomas Zeller, MD

    Herz Zentrum Bad Krozingen, Germany

    PRINCIPAL INVESTIGATOR

  • Dierk Scheinert, MD

    University of Leipzig

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

February 1, 2006

Primary Completion

July 1, 2007

Study Completion

February 1, 2008

Last Updated

July 9, 2009

Results First Posted

July 9, 2009

Record last verified: 2009-05