Status:
TERMINATED
Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis
Lead Sponsor:
VIVA Physicians
Collaborating Sponsors:
W.L.Gore & Associates
Spectranetics Corporation
Conditions:
Restenosis
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00712257
Start Date
November 1 2007
End Date
August 1 2009
Last Update
June 4 2014
Active Locations (1)
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1
Gary Ansel, MD
Columbus, Ohio, United States, 43214