SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients

Study Overview
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Brief Summary
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The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.

Detailed Description
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The present study is designed as a prospective, open label, observational study. The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done. Patients elected for endovascular revascularization with SuperSub strategy will be asked their written consent to the use of their personal data. Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in symptomatic patients, as clinically indicated and with the aim for a new treatment.

Official Title
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SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients

Conditions
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PAD

Intervention / Treatment
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* Device: Stent Peripheral System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria: Patients with CLI and TASC C-D Fem-Pop CTO's Age ≥18 years Patient has signed an approved consent form Patients without previous stenting of the Fem-Pop segment Angiographic Inclusion Criteria: Patent and hemodynamically normal iliac and common femoral arteries. At least one patent and healthy tibial vessel runoff to the foot. Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure Rutherford Category 4, 5 or 6 Subintimal crossing of the occluded Fem-Pop vessels Supera Stenting From healthy to healthy arterial segment. Exclusion Criteria: Patient unwilling or unlikely to comply with Follow-Up schedule Endoluminal crossing of the CTO Inability to stent from healthy to healthy arterial segments. Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Stent Peripheral System|Peripheral PTA with Supera Stent implantation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency Rate | Primary Patency is defined as freedom from clinically driven TLR (CD-TLR) defined as repeat percutaneous intervention or surgical bypass graft to treat an angiographic significant restenosis (>50%) at the level of the treated lesion ±10 mm (proximally and/or distally) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Restenosis | Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography) | 12 months | 
| Freedom from Restenosis | Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography) | 24 months | 
| Composite of All Major Adverse Events | Incidence of the composite of all Major Adverse Events | 12 Months | 
| Composite of All Major Adverse Events | Incidence of the composite of all Major Adverse Events | 24 Months | 
| Incidence of Major Adverse Events | Incidence of Major Adverse Events | 12 months | 
| Incidence of Major Adverse Events | Incidence of Major Adverse Events | 24 months | 
| Stent integrity assessment | Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images | 12 months | 
| Stent integrity assessment | Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images | 24 months | 
| Primary Sustained Clinical Improvement | Clinical Improvement as assessed by Rutherford Class changes | 6,12 and 24 months vs baseline | 
| Quality of Life (EQ-5D-5L Questionnaire) | Quality of Life improvement as assessed by EQ-5D-5L Questionnaire Parameters [Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression] Values [(1) No Problems, (2) Slight Problems, (3) Moderate Problems, (4) Severe Problems, (5) Unable to] Value [1 - Best score, Value 5 - Worse Score] | 6 months | 
| Quality of Life improvement (SF12 Questionnaire) | Quality of Life improvement as assessed by SF12 Questionnaire Parameters [Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health] Values for Overall Health [ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor] Values for Role and Physical health [ 1-Very limiting, 2-Partially limiting, 3-Not limiting] Values for Physical health [ 1-yes, 2-no], [1- best score] , [2-worse score] Values for Role and Mental health [ 1-yes, 2-no], [1- best score] , [2-worse score] Values for Mental Health [ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor] | 6 months | 
| Quality of Life (EQ-5D-5L Questionnaire) | Quality of Life improvement as assessed by EQ-5D-5L Questionnaire Parameters [Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression] Values [(1) No Problems, (2) Slight Problems, (3) Moderate Problems, (4) Severe Problems, (5) Unable to] Value 1 - Best score, Value 5 - Worse Score | 12 months | 
| Quality of Life improvement (SF12 Questionnaire) | Quality of Life improvement as assessed by SF12 Questionnaire Parameters [Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health] Values for Overall Health [ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor] Values for Role and Physical health [ 1-Very limiting, 2-Partially limiting, 3-Not limiting] Values for Physical health [ 1-yes, 2-no], [1- best score] , [2-worse score] Values for Role and Mental health [ 1-yes, 2-no], [1- best score] , [2-worse score] Values for Mental Health [ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor] | 12 months | 
| Quality of Life (EQ-5D-5L Questionnaire) | Quality of Life improvement as assessed by EQ-5D-5L Questionnaire Parameters [Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression] Values [(1) No Problems, (2) Slight Problems, (3) Moderate Problems, (4) Severe Problems, (5) Unable to] Value 1 - Best score, Value 5 - Worse Score | 24 months | 
| Quality of Life improvement | Quality of Life improvement as assessed by SF12 Questionnaire Parameters [Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health] Values for Overall Health [ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor] Values for Role and Physical health [ 1-Very limiting, 2-Partially limiting, 3-Not limiting] Values for Physical health [ 1-yes, 2-no], [1- best score] , [2-worse score] Values for Role and Mental health [ 1-yes, 2-no], [1- best score] , [2-worse score] Values for Mental Health [ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor] | 24 months | 
| Amputation Rates | Major and Minor amputations | 1 month | 
| Amputation Rates | Major and Minor amputations | 6 months | 
| Amputation Rates | Major and Minor amputations | 12 months | 
| Amputation Rates | Major and Minor amputations | 24 months |