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

Restenosis Clinical Trial

— SALVAGE  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00712257
• Other study ID #: SALVAGE - 00106-661
• Status: Terminated
• Phase: N/A
• First received: July 3, 2008
• Last updated: June 2, 2014
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2014
• Source: VIVA Physicians
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Restenosis

Intervention

Device:
• Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
treatment for superficial femoral artery instent re-stenosis

Locations

Country	Name	City	State
United States	Gary Ansel, MD	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
VIVA Physicians	Spectranetics Corporation, W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months
Secondary	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.		12 month follow up