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Completed

NCT Number: NCT00541307

GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA 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.

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Key information

Conditions

Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-City Medical Center, Oceanside, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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  • 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

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  • 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

Treatment and study plan

Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Device

Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Primary outcomes

  1. Primary Patency at 12 Months

    Time frame: 12 months

    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).

Secondary outcomes

  1. Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days

    Time frame: 30 days

    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.

  2. Primary Assisted Patency

    Time frame: 12 months

    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.

  3. Secondary Patency

    Time frame: 12 months

    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.

  4. Device-related Major Adverse Events at 12 Months

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)

Acronym: VIPER

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2007
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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