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NCT00541307 · ClinicalTrials.gov registry record · NA
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
A NA study of Peripheral Vascular Diseases, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
- 5
- Study locations
NCT00541307: Completed NA study of Peripheral Vascular Diseases, sponsored by W.L.Gore & Associates.
NCT00541307 is a NA study of Peripheral Vascular Diseases that has completed, run by W.L.Gore & Associates. The registered enrollment target is 119 participants, below the 490-participant average among 19 other Peripheral Vascular Diseases trials with a reported enrollment target (76% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00541307, a NA study of Peripheral Vascular Diseases, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DEVICE Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Study Locations (5)
California
- Tri-City Medical Center - Oceanside
Illinois
- Mercy Hospital and Medical Center - Chicago
Missouri
- Columbia Surgical Associates - Columbia
Texas
- Baylor University Medical Center - Dallas
Wisconsin
- St. Luke's Medical Center - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-06 |
| Phase | NA |
What the finished NCT00541307 record still lists
NCT00541307 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 490-participant average among 19 other Peripheral Vascular Diseases trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Peripheral Vascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is the first listed.
NCT00541307 lists 5 locations in 5 states (California, Illinois, Missouri).
Frequently Asked Questions
What is clinical trial NCT00541307 about?
NCT00541307 is a clinical study titled "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.
What is the current status of trial NCT00541307?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2007-10. Estimated completion is 2011-06.
What conditions does trial NCT00541307 study?
This clinical trial studies the following conditions: Peripheral Vascular Diseases.
What interventions are being tested in trial NCT00541307?
The interventions under investigation include: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (DEVICE).
Who is sponsoring clinical trial NCT00541307?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00541307 being conducted?
This trial has 5 study locations across California, Illinois, Missouri, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Peripheral Vascular Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00541307's enrollment target sits among peer trials
119 12th of 19 higher than 8 of 19 other Peripheral Vascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Vascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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