Femoropopliteal Artery Stenosis, Peripheral Artery Disease, Peripheral Vascular Disease
Conditions
Keywords
Femoral artery stenosis, Peripheral vascular Disease
Brief summary
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.
Detailed description
This registry follows up to 200 patients for at least 5 years. The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.
Interventions
DEVICESUPERA Interwoven self-expanding nitinol stent
Insertion of stent at stenotic area
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Exclusion criteria
(Clinical) * Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided). * Rutherford-Becker classification 2 through 5 only * Patient is at least 18 years of age and of legal age of consent. * Patient must be willing to participate in the registry for at least 5 years. (Angiographic) * Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion * All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery. * All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk. * Target lesion length 1-20 cm (visual estimate) * Target lesion stenosis ≥50% (visual estimate) * Popliteal artery patent if the lesion is in the SFA * SFA patent if the lesion is in the popliteal artery * At least one widely patent (\< 50% stenosis) infrapopliteal artery (for distal run-off)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute Walking Distance | At baseline | The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Peri-procedural and Post-procedural Complications | 30 days | Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation. |
| Rutherford-Becker Clinical Category | 30 days | Rutherford/Becker Categories: 0 - Asymptomatic, no hemodynamically significant occlusive disease. 1. \- Mild claudication. 2. \- Moderate claudication. 3. \- Severe claudication. 4. \- Ischemic rest pain. 5. \- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia. 6. \- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. |
| Restenosis by Duplex Ultrasound | 6 months | In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis. |
| Number of Participants Experiencing Peri-procedural and Post-procedural Complications | 30 days | Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation. |
| Stent Fracture | 1 Year | Stent fractures determined by fluoroscopy . |
| Target Limb Ankle Brachial Index (at Rest) | At baseline | Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease. |
| Six-minute Walking Distance | 2 Years | The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication. |
| Target Lesion Revascularization | 6 months | Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion). |
Countries
Germany
Participant flow
Recruitment details
This study planned to recruit up to 200 patients across 5-10 sites in the European Union. However, during the course of the study, intake was halted at 109 patients and the registry was terminated early because of slow enrollment, increased loss to follow-ups, and general lack of interest.
Participants by arm
| Arm | Count |
|---|---|
| Device SUPERA Stent SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area | 109 |
| Total | 109 |
Baseline characteristics
| Characteristic | Device SUPERA Stent |
|---|---|
| Age, Continuous | 71 Years STANDARD_DEVIATION 8.8 |
| Lesion length Femoropopliteal conjunction (n=3) | 18.67 Centimeters STANDARD_DEVIATION 2.31 |
| Lesion length Popliteal (n=22) | 7.77 Centimeters STANDARD_DEVIATION 5 |
| Lesion length Superficial femoral (n=86) | 16.40 Centimeters STANDARD_DEVIATION 28.93 |
| Occlusion | 50 participants |
| Percent diameter stenosis Femoropopliteal conjunction (n=3) | 96.67 percentage diameter stenosis STANDARD_DEVIATION 5.77 |
| Percent diameter stenosis Popliteal (n=23) | 93.83 percentage diameter stenosis STANDARD_DEVIATION 7.91 |
| Percent diameter stenosis Superficial femoral (n=87) | 93.07 percentage diameter stenosis STANDARD_DEVIATION 8.78 |
| Region of Enrollment Germany | 109 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 87 / 109 |
| serious Total, serious adverse events | 84 / 109 |
Outcome results
Primary
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time frame: At baseline
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Six-minute Walking Distance | 171.30 Meters | Standard Deviation 85.93 |
Primary
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time frame: 30 days
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Six-minute Walking Distance | 251.77 Meters | Standard Deviation 119.44 |
Primary
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time frame: 6 months
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Six-minute Walking Distance | 263.74 Meters | Standard Deviation 152.95 |
Primary
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time frame: 1 Year
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Six-minute Walking Distance | 262.19 Meters | Standard Deviation 141.13 |
Secondary
Number of Participants Experiencing Peri-procedural and Post-procedural Complications
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device SUPERA Stent | Number of Participants Experiencing Peri-procedural and Post-procedural Complications | At least one | 3 Participants |
| Device SUPERA Stent | Number of Participants Experiencing Peri-procedural and Post-procedural Complications | AV fistula / pseudoaneurysm | 2 Participants |
| Device SUPERA Stent | Number of Participants Experiencing Peri-procedural and Post-procedural Complications | Subacute occlusion | 2 Participants |
| Device SUPERA Stent | Number of Participants Experiencing Peri-procedural and Post-procedural Complications | Hematoma | 1 Participants |
Secondary
Number of Peri-procedural and Post-procedural Complications
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device SUPERA Stent | Number of Peri-procedural and Post-procedural Complications | At least one | 5 Number of compilcations |
| Device SUPERA Stent | Number of Peri-procedural and Post-procedural Complications | AV fistula / pseudoaneurysm | 2 Number of compilcations |
| Device SUPERA Stent | Number of Peri-procedural and Post-procedural Complications | Subacute occlusion | 2 Number of compilcations |
| Device SUPERA Stent | Number of Peri-procedural and Post-procedural Complications | Hematoma | 1 Number of compilcations |
Secondary
Restenosis by Duplex Ultrasound
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Time frame: 6 months
Population: If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.~The number of patients analyzed is based on the data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device SUPERA Stent | Restenosis by Duplex Ultrasound | PSVR ≥ 2.4 | 11.0 percentage of participants |
| Device SUPERA Stent | Restenosis by Duplex Ultrasound | PSVR ≥ 2.5 | 9.9 percentage of participants |
Secondary
Restenosis by Duplex Ultrasound
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Time frame: 1 Year
Population: If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.~The number of patients analyzed is based on the data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device SUPERA Stent | Restenosis by Duplex Ultrasound | PSVR ≥ 2.4 | 23.2 percentage of participants |
| Device SUPERA Stent | Restenosis by Duplex Ultrasound | PSVR ≥ 2.5 | 19.5 percentage of participants |
Secondary
Rutherford-Becker Clinical Category
Rutherford/Becker Categories: 0 - Asymptomatic, no hemodynamically significant occlusive disease. 1. \- Mild claudication. 2. \- Moderate claudication. 3. \- Severe claudication. 4. \- Ischemic rest pain. 5. \- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia. 6. \- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Time frame: 30 days
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device SUPERA Stent | Rutherford-Becker Clinical Category | 0 = Asymptomatic | 41.7 percentage of participants |
| Device SUPERA Stent | Rutherford-Becker Clinical Category | 1 = Mild claudication | 19.8 percentage of participants |
| Device SUPERA Stent | Rutherford-Becker Clinical Category | 2 = Moderate claudication | 18.8 percentage of participants |
| Device SUPERA Stent | Rutherford-Becker Clinical Category | 3 = Severe claudication | 13.5 percentage of participants |
| Device SUPERA Stent | Rutherford-Becker Clinical Category | 4 = Ischemic rest pain | 0.0 percentage of participants |
| Device SUPERA Stent | Rutherford-Becker Clinical Category | 5 = Minor tissue loss | 5.2 percentage of participants |
| Device SUPERA Stent | Rutherford-Becker Clinical Category | 6 = Ulceration or gangrene | 1.0 percentage of participants |
Secondary
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time frame: 2 Years
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Six-minute Walking Distance | 272.75 Meters | Standard Deviation 152.8 |
Secondary
Stent Fracture
Stent fracture and Involuntary stent migration are types of device System Failure. Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Time frame: 1 to 3 Years
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device SUPERA Stent | Stent Fracture | 0 participants |
Secondary
Stent Fracture
Stent fractures determined by fluoroscopy .
Time frame: 1 Year
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device SUPERA Stent | Stent Fracture | 2 participants |
Secondary
Stent Fracture
Stent fracture and Involuntary stent migration are types of device System Failure. Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Time frame: 1 to 2 years
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device SUPERA Stent | Stent Fracture | 0 participants |
Secondary
Target Lesion Revascularization
Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament. Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)
Time frame: 1 Year
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device SUPERA Stent | Target Lesion Revascularization | 11.8 percentage of participants |
Secondary
Target Lesion Revascularization
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 6 months
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device SUPERA Stent | Target Lesion Revascularization | 4.1 percentage of participants |
Secondary
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time frame: 30 days
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Target Limb Ankle Brachial Index (at Rest) | 1.04 Ratio | Standard Deviation 0.25 |
Secondary
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time frame: 6 months
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Target Limb Ankle Brachial Index (at Rest) | 0.98 Ratio | Standard Deviation 0.28 |
Secondary
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time frame: 1 Year
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Target Limb Ankle Brachial Index (at Rest) | 0.90 Ratio | Standard Deviation 0.29 |
Secondary
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time frame: 2 Years
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Target Limb Ankle Brachial Index (at Rest) | 0.91 Ratio | Standard Deviation 0.22 |
Secondary
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time frame: At baseline
Population: The number of patients analyzed is based on the data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device SUPERA Stent | Target Limb Ankle Brachial Index (at Rest) | 0.63 Ratio | Standard Deviation 0.29 |