Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis - Full Text View

Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis (SALVAGE)

This study is currently recruiting participants.

Verified by VIVA Physicians, July 2008

First Received: July 3, 2008 Last Updated: July 8, 2008 History of Changes

Sponsors and Collaborators:	VIVA Physicians W.L.Gore & Associates Spectranetics Corporation
Information provided by:	VIVA Physicians
ClinicalTrials.gov Identifier:	NCT00712257

Purpose

A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis

Condition	Intervention
Restenosis	Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis.

Resource links provided by NLM:

Drug Information available for: Heparin

U.S. FDA Resources

Further study details as provided by VIVA Physicians:

Primary Outcome Measures:

12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure. [ Time Frame: 12 month follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

treatment for superficial femoral artery instent re-stenosis

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject or subject's legal representative informed of the study nature.
Subject understands the duration of the study and its follow up visit requirements.
Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
Subject able to walk unassisted.
Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.

Exclusion Criteria:

Life expectancy less than 12 months
Myocardial infarction less than 3 months prior to procedure
Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
Uncontrolled hypercoagulability

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712257

Contacts

Contact: John Laird, Jr., MD

916-734-2028

John.laird@ucdmc.ucdavis.edu

Locations

United States, Ohio
Gary Ansel, MD	Recruiting
Columbus, Ohio, United States, 43214

Sponsors and Collaborators

VIVA Physicians

W.L.Gore & Associates

Spectranetics Corporation

Investigators

Principal Investigator:

Tony Das, MD

Presbyterian Heart Institute

More Information

No publications provided

Responsible Party:	VIVA Physicians ( VIVA Physicians - Dr. John Laird, Jr. - PI )
Study ID Numbers:	SALVAGE - 00106-661
Study First Received:	July 3, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00712257 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVA Physicians:

treatment of superficial femoral artery instent restenosis

Study placed in the following topic categories:

Heparin
Calcium heparin

ClinicalTrials.gov processed this record on September 03, 2009