Data Registry Following Patients Using Supera Stent in the Femoral Arteries

Study Overview
=================
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.

Official Title
-----------------
Supera Treatment Registry Observing Neointimal Growth

Conditions
-----------------
Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: SUPERA Interwoven self-expanding nitinol stent


Participation Criteria
=================
Eligibility Criteria
-----------------
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) Exclusion Criteria: (Clinical) Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities Patient is participating in a clinical study that could confound results Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry. (Angiographic) Target lesion length > 20 cm Instent restenotic / reoccluded target lesion Acute (≤ 4 weeks) thrombotic occlusion Untreated ipsilateral pelvic stenosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device SUPERA Stent<br>SUPERA Interwoven Self-Expanding Nitinol Stent System | Device: SUPERA Interwoven self-expanding nitinol stent<br>* Insertion of stent at stenotic area<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline | 
| 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. | 30 days | 
| 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. | 6 months | 
| 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. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 
| 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. | 30 days | 
| Rutherford-Becker Clinical Category | Rutherford/Becker Categories: 0 - Asymptomatic, no hemodynamically significant occlusive disease. - Mild claudication. - Moderate claudication. - Severe claudication. - Ischemic rest pain. - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia. - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. | 30 days | 
| 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. | 6 months | 
| 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. | 1 Year | 
| 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). | 6 months | 
| 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.) | 1 Year | 
| Stent Fracture | Stent fractures determined by fluoroscopy . | 1 Year | 
| 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. | 1 to 2 years | 
| 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. | 1 to 3 Years | 
| 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. | At baseline | 
| 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. | 30 days | 
| 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. | 6 months | 
| 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. | 1 Year | 
| 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. | 2 Years | 
| 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. | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral artery stenosis, Peripheral vascular Disease