Determining Predictors of Restenosis in Femoropopliteal Lesions

Study Overview
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Brief Summary
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A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Detailed Description
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Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior. However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment. The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.

Official Title
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Determining Predictors of Restenosis. Intravascular Ultrasound in the Treatment of Femoropopliteal Lesions

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries; Successful lesion passage passed with conventional mechanical guidewires; Symptomatic critical limb ischemia (Rutherford 4, 5, 6); Life-expectancy of more than 12 months; Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study; Te patient must provide written patient informed consent that is approved by the ethics committee. Exclusion Criteria: Patient refusing treatment; The reference segment diameter is not suitable fo available balloon and/or stent design; Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis; Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site; The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies; The patent has a history of prior life-threatening contrast media reaction; The patient is currently enrolled in another investigational device or drug trial; The patient is currently breast-feeding, pregnant or intends to become pregnant; The patient is mentally ill or retarded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravascular Ultrasound data<br>Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions. | Device: Ultrasound<br>* Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Burden Measure | defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area | intraoperative | 
| Reference Lumen Measure | defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5 | intraoperative | 
| Reference Diameter Measure | defined as = (proximal reference diameter + distal reference diameter) x 0.5 | intraoperative | 
| Stent/reference Diameter Ratio Measure | defined as = stent diameter ÷ reference diameter | intraoperative | 
| Stent Expansion Ratio Measure | defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area | intraoperative | 
| Radial Stent Symmetry Index Measure | defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area | intraoperative | 
| Axial Stent Symmetry Index Measure | defined as = minimum ÷ maximum stent cross-sectional area | intraoperative | 
| In Stent Restenosis |  | 12 months (±30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater tha 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. | intraoperative | 
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | Baseline | 
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 1 month (± 7 days) | 
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 3 months (±30 days) | 
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 6 months (±30 days) | 
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 12 months (±30 days) | 
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | Baseline | 
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 1 month (± 7 days) | 
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 3 months (±30 days) | 
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 6 months (±30 days) | 
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 12 months (±30 days) | 
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | Baseline | 
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 1 month (± 7 days) | 
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 3 months (±30 days) | 
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 6 months (±30 days) | 
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 12 months (±30 days) | 
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | Baseline | 
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 1 month (± 7 days) | 
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 3 months (±30 days) | 
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 6 months (±30 days) | 
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 12 months (±30 days) |