Peripheral Vascular Diseases
Conditions
Brief 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.
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.
Interventions
Implantation
DEVICEBare Nitinol Stent
Implantation
Sponsors
W.L.Gore & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Primary Patency at Three Years | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success at Initial Procedure | Time of implant 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. |
| Target Vessel Revascularization (TVR) | 3 years | This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study. |
| Target Lesion Revascularization (TLR) | 3 years | 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. |
| Improvement in Rutherford Classification (Clinical Success) | 3 years | 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. |
| Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | 3 years | 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. |
| Primary Assisted Patency | 3 years | 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. |
| Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | 3 years | 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. |
| Change in Ankle-Brachial Index (ABI) | 3 years | 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. |
| Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) | 3 years | 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. |
| Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0) | 3 years | 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. |
| Occurrence of Stent Fracture | 1 year | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays. |
| Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | 3 years | 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. |
| Secondary Patency | 3 years | Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE VIABAHN Endoprosthesis Subjects randomized to this group received the Gore VIABAHN Endoprosthesis. | 72 |
| Bare Nitinol Stent Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care. | 76 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 9 | 3 |
| Overall Study | Lost to Follow-up | 6 | 10 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Surgical Intervention (bypass) | 5 | 5 |
| Overall Study | Withdrawal by Subject | 9 | 10 |
Baseline characteristics
| Characteristic | GORE VIABAHN Endoprosthesis | Bare Nitinol Stent | Total |
|---|---|---|---|
| Age Continuous | 69 years | 63 years | 67 years |
| Region of Enrollment United States | 72 participants | 76 participants | 148 participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Male | 45 Participants | 49 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 72 | 4 / 76 |
| serious Total, serious adverse events | 25 / 72 | 24 / 76 |
Outcome results
Primary
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).
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Efficacy: Primary Patency at Three Years | 24.2 percentage of subjects |
| Bare Nitinol Stent | Efficacy: Primary Patency at Three Years | 25.9 percentage of subjects |
Primary
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Safety: Composite of Major Procedural (30-day) Adverse Events (AEs) | 1.4 percentage of subjects |
| Bare Nitinol Stent | Safety: Composite of Major Procedural (30-day) Adverse Events (AEs) | 0 percentage of subjects |
Secondary
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0) | 31.3 percentage of subjects |
| Bare Nitinol Stent | Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0) | 29.2 percentage of subjects |
Secondary
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) | 27.2 percentage of subjects |
| Bare Nitinol Stent | Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) | 28.6 percentage of subjects |
Secondary
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.
Time frame: 3 years
Population: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GORE VIABAHN Endoprosthesis | Change in Ankle-Brachial Index (ABI) | Baseline Mean | 0.64 ABI Value | Standard Deviation 0.15 |
| GORE VIABAHN Endoprosthesis | Change in Ankle-Brachial Index (ABI) | 36-month Mean | 0.95 ABI Value | Standard Deviation 0.18 |
| Bare Nitinol Stent | Change in Ankle-Brachial Index (ABI) | Baseline Mean | 0.67 ABI Value | Standard Deviation 0.16 |
| Bare Nitinol Stent | Change in Ankle-Brachial Index (ABI) | 36-month Mean | 0.97 ABI Value | Standard Deviation 0.16 |
Secondary
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.
Time frame: 3 years
Population: The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Improvement in Rutherford Classification (Clinical Success) | 86.7 percentage of participants |
| Bare Nitinol Stent | Improvement in Rutherford Classification (Clinical Success) | 91.7 percentage of participants |
Secondary
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.
Time frame: 3 years
Population: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Occurrence of Stent Fracture | 2.6 percentage of participants |
| Bare Nitinol Stent | Occurrence of Stent Fracture | 50.0 percentage of participants |
Secondary
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.
Time frame: 1 year
Population: The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Occurrence of Stent Fracture | 2.1 percentage of particpants |
| Bare Nitinol Stent | Occurrence of Stent Fracture | 32.7 percentage of particpants |
Secondary
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.
Time frame: 2 years
Population: The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Occurrence of Stent Fracture | 4.7 percentage of participants |
| Bare Nitinol Stent | Occurrence of Stent Fracture | 48.9 percentage of participants |
Secondary
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Primary Assisted Patency | 69.8 percentage of subjects |
| Bare Nitinol Stent | Primary Assisted Patency | 88.8 percentage of subjects |
Secondary
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.
Time frame: 3 years
Population: Number of subjects that returned for 3yr follow-up appointment and completed the ICQ.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GORE VIABAHN Endoprosthesis | Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | Baseline | 46.6 Score | Standard Deviation 20.1 |
| GORE VIABAHN Endoprosthesis | Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | 36month | 20.8 Score | Standard Deviation 19.6 |
| Bare Nitinol Stent | Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | Baseline | 50.1 Score | Standard Deviation 18.2 |
| Bare Nitinol Stent | Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | 36month | 22.9 Score | Standard Deviation 21.2 |
Secondary
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.
Time frame: 3 years
Population: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GORE VIABAHN Endoprosthesis | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | Baseline mean score | 50.3 Score | Standard Deviation 12.8 |
| GORE VIABAHN Endoprosthesis | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | 36-month Mean | 54 Score | Standard Deviation 9.1 |
| Bare Nitinol Stent | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | Baseline mean score | 48.3 Score | Standard Deviation 11.6 |
| Bare Nitinol Stent | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | 36-month Mean | 54 Score | Standard Deviation 8.6 |
Secondary
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.
Time frame: 3 years
Population: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GORE VIABAHN Endoprosthesis | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | Baseline Mean | 33.6 Score | Standard Deviation 9.9 |
| GORE VIABAHN Endoprosthesis | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | 36-month Mean | 41.9 Score | Standard Deviation 11.7 |
| Bare Nitinol Stent | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | Baseline Mean | 32.9 Score | Standard Deviation 8.5 |
| Bare Nitinol Stent | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | 36-month Mean | 38.7 Score | Standard Deviation 10.5 |
Secondary
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Secondary Patency | 79.5 percentage of subjects |
| Bare Nitinol Stent | Secondary Patency | 89.3 percentage of subjects |
Secondary
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Target Lesion Revascularization (TLR) | 34.7 percentage of participants |
| Bare Nitinol Stent | Target Lesion Revascularization (TLR) | 34.2 percentage of participants |
Secondary
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Target Vessel Revascularization (TVR) | 37.5 percentage of participants |
| Bare Nitinol Stent | Target Vessel Revascularization (TVR) | 35.5 percentage of participants |
Secondary
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.
Time frame: Time of implant procedure
Population: The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABAHN Endoprosthesis | Technical Success at Initial Procedure | 97.3 percentage of subjects |
| Bare Nitinol Stent | Technical Success at Initial Procedure | 85.7 percentage of subjects |