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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

May 8, 2008
May 18, 2009
February 2006
July 2007   (final data collection date for primary outcome measure)
Major Adverse Events (MAEs) Within 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00676494 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Artery Disease
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.
Not Provided
Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, Bosiers M, Peeters P, Balzer JO, Gray W, Tübler T, Wissgott C, Schwarzwälder 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
February 2008
July 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00676494
PTC 05003
Yes
Kevin Peters, Director of Clinical Affairs, Pathway Medical Technologies Inc.
Pathway Medical Technologies Inc.
Not Provided
Principal Investigator: Thomas Zeller, MD Herz Zentrum Bad Krozingen, Germany
Principal Investigator: Dierk Scheinert, MD University of Leipzig, Germany
Pathway Medical Technologies Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP