Peripheral Vascular DiseasesVIPERNCT00541307
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
A study testing Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mercy Hospital and Medical Center
Chicago, Illinois, 60616
Columbia Surgical Associates
Columbia, Missouri, 65201
Baylor University Medical Center
Dallas, Texas, 75226
St. Luke's Medical Center
Milwaukee, Wisconsin, 53233
Tri-City Medical Center
Oceanside, California, 92056
About this study
Official title: 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.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Keywords
- Peripheral Arterial Disease, Peripheral Vascular Disease
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| GORE VIABHAN Endoprothesis | Experimental | Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface Receives: Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 30 days
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Saxon, MD, Principal investigator, North County Radiology Medial Group Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541307
- Sponsor's protocol ID
- VPR 07-03
- Acronym
- VIPER
- Status last verified
- Nov 2012
- First submitted
- 9 Oct 2007
- Last updated
- 27 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)
- ClinicalTrials.gov ID
- NCT00541307
- Acronym / sponsor ID
- VIPER / VPR 07-03
- Conditions
- Peripheral Vascular Diseases
- Keywords
- Peripheral Arterial Disease, Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Posted 27 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE VIABHAN Endoprothesis | Experimental | Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive SurfaceTreatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive SurfaceEndovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface | Device | GORE VIABHAN Endoprothesis |
Primary outcome
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).
4 secondary outcomes
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 Patency
Time frame: 12 months
Device-related Major Adverse Events at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Saxon, MD principal investigator
North County Radiology Medial Group Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2012.