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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014