NCT00541307

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 27, 2012

Completed
Last Updated

December 27, 2012

Status Verified

November 1, 2012

Enrollment Period

3.7 years

First QC Date

October 9, 2007

Results QC Date

June 22, 2012

Last Update Submit

November 26, 2012

Conditions

Peripheral Vascular Diseases

Keywords

Peripheral Arterial DiseasePeripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

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

    30 days

  • Primary Assisted Patency

    12 months

  • Secondary Patency

    12 months

  • Device-related Major Adverse Events at 12 Months

    12 months

Study Arms (1)

GORE VIABHAN Endoprothesis

EXPERIMENTAL

Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Interventions

Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive SurfaceDEVICE

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

GORE VIABHAN Endoprothesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tri-City Medical Center

Oceanside, California, 92056, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Columbia Surgical Associates

Columbia, Missouri, 65201, United States

Location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Peripheral Vascular DiseasesPeripheral Arterial Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Results Point of Contact

Title
Chad Badorek
Organization
W. L. Gore & Associates, Inc.
cbadorek@wlgore.com
928/437-8181

Study Officials

  • Richard Saxon, MD

    North County Radiology Medial Group Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 27, 2012

Results First Posted

December 27, 2012

Record last verified: 2012-11

Locations

US(5)