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

Peripheral Vascular Diseases Clinical Trial

— VIPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541307
• Other study ID #: VPR 07-03
• Status: Completed
• Phase: N/A
• First received: October 9, 2007
• Last updated: November 26, 2012
• Start date: October 2007
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	Columbia Surgical Associates	Columbia	Missouri
United States	Baylor University Medical Center	Dallas	Texas
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Tri-City Medical Center	Oceanside	California

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency at 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).	12 months	No
Secondary	Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 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.	30 days	Yes
Secondary	Primary Assisted Patency	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.	12 months	No
Secondary	Secondary Patency	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.	12 months	No
Secondary	Device-related Major Adverse Events at 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.	12 months	Yes