Peripheral Vascular DiseasesPhase 4NCT00228384
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
A Phase 4 study testing GORE VIABAHN Endoprosthesis and Bare Nitinol Stent in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates at 15 sites in United States.
Trial summary
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- GORE VIABAHN Endoprosthesis and Bare Nitinol Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2005to Jan 2011
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lifestyle-limiting claudication or rest pain.
- Subject (or their legal guardian) has read, understood and provided written informed consent.
- At least 21 years of age.
- Quality of life questionnaires completed.
- Noninvasive lower extremity arterial studies within 45-days prior to study procedure.
- If applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study procedure.
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- If applicable, vascular treatment on non-study leg for bilateral claudication ≥ 14-days prior to study procedure.
- Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test.
- Projected life expectancy of greater than three years.
- The ability to comply with protocol.
- Angiographic and Lesion Requirements meets protocol criteria.
Who cannot join
- Untreated flow-limiting aortoiliac occlusive disease.
- Any previous stenting or surgery in the target vessel.
- Subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm.
- Severe ipsilateral common femoral/profunda disease requiring surgical intervention.
- Femoral or popliteal aneurysm.
- Non-atherosclerotic disease resulting in occlusion.
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- Tibial artery disease requiring treatment.
- Prior ipsilateral femoral artery bypass.
- Severe medical comorbidities.
- Popliteal artery vascular access at any time during procedure.
- Antegrade and retrograde vascular access on the same common femoral artery at the time of the SFA intervention.
- Serum creatinine > 2.5 mg/dL within 45 days prior to study procedure.
- Major distal amputation.
- Septicemia.
- Any previously known coagulation disorder.
- Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
- Contraindication to anticoagulation or antiplatelet therapy.
- Known allergies to stent/stent-graft components.
- History of prior life-threatening reaction to contrast agent.
- Currently participating in another clinical research trial.
- Current peritoneal or hemodialysis.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Vascular Surgical Associate
Austell, Georgia, 30106
Heritage Valley Health Systems
Beaver, Pennsylvania, 15009
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Midwest Cardiology Research Foundation
Columbus, Ohio, 43214
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Arkansas Heart
Little Rock, Arkansas, 72211
Midwest Heart Foundation
Lombard, Illinois, 60148
Midwest Institute for Minimally Invasive Therapy
Melrose Park, Illinois, 60160
St Luke's Medical Center
Milwaukee, Wisconsin, 53215
Ochsner Clinic
New Orleans, Louisiana, 70121
St Francis Medical Center
Peoria, Illinois, 61637
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Allegheney General Hospital
Pittsburgh, Pennsylvania, 15212
St. Johns Hospital/Prairie Education Research
Springfield, Illinois, 62701
Washington University
St Louis, Missouri, 63110
About this study
Official title: GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
Read the detailed description
This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- GORE VIABAHN Endoprosthesis, Bare Nitinol Stent
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE VIABAHN EndoprosthesisDevice
Also called VIABAHN
Implantation
Bare Nitinol StentDevice
Implantation
| Study group | Role | What they receive |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Active comparator | Not described Receives: Device: GORE VIABAHN Endoprosthesis |
| Bare Nitinol Stent (BNS) | Active comparator | Not described Receives: Device: Bare Nitinol Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Primary Patency at Three Years
Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention.
The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years).
Measured: 3 years
Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.
Measured: 30 days
Secondary outcomes (15)
Primary Assisted Patency
Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion.
Measured: 3 years
Secondary Patency
Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Measured: 3 years
Technical Success at Initial Procedure
Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow.
The results show the percentage of study subjects that had technical success.
Measured: Time of implant procedure
Target Vessel Revascularization (TVR)
This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.
Measured: 3 years
Target Lesion Revascularization (TLR)
This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.
Measured: 3 years
Improvement in Rutherford Classification (Clinical Success)
The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.
Measured: 3 years
Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)
The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire.
Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline.
Measured: 3 years
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)
The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline.
Measured: 3 years
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)
The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline.
Measured: 3 years
Change in Ankle-Brachial Index (ABI)
This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.
A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal.
An outcome of a higher mean ABI is considered a success.
Measured: 3 years
Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)
The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5.
Measured: 3 years
Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)
The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0.
Measured: 3 years
Occurrence of Stent Fracture
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.
Measured: 1 year
Occurrence of Stent Fracture
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.
Measured: 2 years
Occurrence of Stent Fracture
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2011
- Study completionJan 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Ansel, MD, Principal investigator, Midwest CardiologyPatrick Geraghty, MD, Principal investigator, Washington University School of MedicineMark Mewissen, MD, Principal investigator, St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228384
- Sponsor's protocol ID
- SFA 05-03
- Status last verified
- May 2012
- First submitted
- 26 Sep 2005
- Last updated
- 4 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM; VIBRANT Investigators. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 2013 Aug;58(2):386-95.e4. doi: 10.1016/j.jvs.2013.01.050. Epub 2013 May 13.
PubMed 23676191
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
- ClinicalTrials.gov ID
- NCT00228384
- Acronym / sponsor ID
- SFA 05-03
- Conditions
- Peripheral Vascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
Detailed description
This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Active comparator | Device: GORE VIABAHN Endoprosthesis |
| Bare Nitinol Stent (BNS) | Active comparator | Device: Bare Nitinol Stent |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Lifestyle-limiting claudication or rest pain.
- Subject (or their legal guardian) has read, understood and provided written informed consent.
- At least 21 years of age.
- Quality of life questionnaires completed.
- Noninvasive lower extremity arterial studies within 45-days prior to study procedure.
Key exclusion criteria (21 listed)
- Untreated flow-limiting aortoiliac occlusive disease.
- Any previous stenting or surgery in the target vessel.
- Subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm.
- Severe ipsilateral common femoral/profunda disease requiring surgical intervention.
- Femoral or popliteal aneurysm.
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 |
|---|---|---|
| GORE VIABAHN EndoprosthesisAlso: VIABAHNImplantation | Device | Gore VIABAHN Endoprosthesis |
| Bare Nitinol StentImplantation | Device | Bare Nitinol Stent (BNS) |
Primary outcome
Efficacy: Primary Patency at Three Years
Time frame: 3 years
Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention. The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years).
Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
Time frame: 30 days
Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.
15 secondary outcomes
Primary Assisted Patency
Time frame: 3 years
Secondary Patency
Time frame: 3 years
Technical Success at Initial Procedure
Time frame: Time of implant procedure
Target Vessel Revascularization (TVR)
Time frame: 3 years
Target Lesion Revascularization (TLR)
Time frame: 3 years
Improvement in Rutherford Classification (Clinical Success)
Time frame: 3 years
Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)
Time frame: 3 years
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)
Time frame: 3 years
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)
Time frame: 3 years
Change in Ankle-Brachial Index (ABI)
Time frame: 3 years
Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)
Time frame: 3 years
Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)
Time frame: 3 years
Occurrence of Stent Fracture
Time frame: 1 year
Occurrence of Stent Fracture
Time frame: 2 years
Occurrence of Stent Fracture
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23676191Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM; VIBRANT Investigators. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 2013 Aug;58(2):386-95.e4. doi: 10.1016/j.jvs.2013.01.050. Epub 2013 May 13.
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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.
Gary Ansel, MD principal investigator
Midwest Cardiology
Patrick Geraghty, MD principal investigator
Washington University School of Medicine
Mark Mewissen, MD principal investigator
St. Luke's Medical Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GORE VIABAHN Endoprosthesis and Bare Nitinol Stent in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates at 15 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 11 inclusion and 21 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 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?
Efficacy: Primary Patency at Three Years (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228384, which also lists 1 linked publication.
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 4 Jun 2012.