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

NCT00712257 | Terminated DMC

• 1 other identifier: SALVAGE - 00106-661
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Restenosis

Keywords

treatment of superficial femoral artery instent restenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Spectranetics Laser plus Gore Viabahn Endoprosthesis

OTHER

Spectranetics Laser for optimal debulking followed by adjunctive PTA plus GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placement

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

Interventions

Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface DEVICE

treatment for superficial femoral artery instent re-stenosis

Spectranetics Laser plus Gore Viabahn Endoprosthesis

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VIVA Physicians: lead
• W.L.Gore & Associates: collaborator
• Spectranetics Corporation: collaborator

Study Sites (1)

Gary Ansel, MD

Columbus, Ohio, 43214, United States

Location

Study Officials

• Tony Das, MD

  Presbyterian Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: August 1, 2009
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)