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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712257

Acronym

SALVAGE

Enrollment

Registered

2008-07-09

Start date

2007-11-30

Completion date

2009-08-31

Last updated

2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restenosis

Keywords

treatment of superficial femoral artery instent restenosis

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

Interventions

DEVICESpectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface

treatment for superficial femoral artery instent re-stenosis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026