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GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00541307
First received: October 9, 2007
Last updated: November 26, 2012
Last verified: November 2012
History of Changes

October 9, 2007
November 26, 2012
October 2007
June 2011   (final data collection date for primary outcome measure)
Primary Patency at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).
Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-coded duplex sonography (CDUS, PSVR <2.5) [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00541307 on ClinicalTrials.gov Archive Site
  • Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
  • Primary Assisted Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency.
  • Secondary Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency.
  • Device-related Major Adverse Events at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
  • Proportion of subjects who experience major device related adverse events within the first 30 days [ Time Frame: 30 days ]
  • Primary assisted patency [ Time Frame: 12 months ]
  • Secondary Assisted Patency [ Time Frame: 12 months ]
  • Device related major adverse events at 12 months [ Time Frame: 12 months ]
Not Provided
Not Provided
 
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)

The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Vascular Diseases
Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Experimental: GORE VIABHAN Endoprothesis
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Intervention: Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:>

  • lifestyle limiting claudication, rest pain or minor tissue loss>
  • ABI (ankle-brachial index) < 0.9 or TBI (toe-brachial index) < 0.5 if ABI is >0.9
  • Stenosis (>50%) or occlusion of native SFA (superficial femoral artery) >5cm
  • Orifice and 1 cm of SFA are patent
  • Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation
  • At least 1 patent run off vessel
  • Guidewire and deliver system successfully traversed the lesion

Exclusion Criteria:>

  • Untreated flow-limiting aortoiliac occlusive disease
  • Any previous stenting or surgery in the target vessel
  • Femoral or popliteal aneurysm of target vessel
  • No patent tibial arteries
  • Prior ipsilateral femoral artery bypass
  • Major distal amputation (above the transmetatarsal) in either limb
  • Patients with known sensitivity to Heparin
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00541307
VPR 07-03
No
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Richard Saxon, MD North County Radiology Medial Group Inc.
W.L.Gore & Associates
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP