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The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

This study has been completed.
Sponsor:
Information provided by:
Pathway Medical Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00676494
First received: May 8, 2008
Last updated: May 18, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
 Device: Pathway PV Atherectomy System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pathway Medical Technologies Inc.:

Primary Outcome Measures:
  • Major Adverse Events (MAEs) Within 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average Rutherford Classification Score at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average Ankle Brachial Index (ABI) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Freedom From Target Lesion Revascularization (TLR) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676494

Sponsors and Collaborators
Pathway Medical Technologies Inc.
Investigators
Principal Investigator: Thomas Zeller, MD Herz Zentrum Bad Krozingen, Germany
Principal Investigator: Dierk Scheinert, MD University of Leipzig, Germany
  More Information

No publications provided by Pathway Medical Technologies Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kevin Peters, Director of Clinical Affairs, Pathway Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT00676494     History of Changes
Other Study ID Numbers: PTC 05003
Study First Received: May 8, 2008
Results First Received: February 23, 2009
Last Updated: May 18, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013