Post-Market Clinical Follow Up of Rotarex®S Catheter

Study Overview
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Brief Summary
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Post-Market Clinical Follow Up of the Rotarex®S Catheter

Detailed Description
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A prospective, multi-center, non-randomized, multiple cohorts, observational, post market clinical follow-up study of the Rotarex®S Catheter to evaluate the safety, technical performance and medical efficacy of the Rotarex®S Catheter as a stand-alone and adjunctive therapy for the treatment of acute, subacute and chronic occlusions and sub-occlusions of arteries outside the cardiopulmonary, coronary and cerebral circulations, in accordance with Rotarex®S Catheter intended use.

Official Title
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Post-Market Clinical Follow Up of Rotarex®S Catheter

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Atherectomy/Thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥18 years old at the time of consent. Subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments. Female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure. Documented symptomatic peripheral arterial disease. Acute, subacute and chronic (sub-) occlusion, with ≥ 90% stenosis in native arteries and/or stents / stent grafts and/or Bypass grafts and/or AV Fistula (Dialysis access). De novo or re-occluded lesion. Vessel and/or stent diameter within treatable range as per Instruction For Use. Occlusion crossed intraluminally by a guidewire. For patients requiring lower limb intervention: Patient presenting with a category from 2 to 5 according to the Rutherford classification for chronic limb ischemia or a category from I to IIb according to the Rutherford classification for acute limb ischemia. Exclusion Criteria: Life expectancy < 2 years. Pregnant or nursing a child. Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated. Myocardial infarction within 60 days prior to index procedure. History of severe trauma and/or sepsis within 60 days prior to index procedure. Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure. Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure. Abnormal electrocardiogram or blood test results and/or any other factor that would increase risk by participating in the study in the opinion of the investigator. Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only). Additional lesion that is located >3cm away from the target lesion Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter. Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint. Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics. Patients with uncorrected bleeding disorders. Thrombophlebitis or deep vein thrombosis within the past 30 days.

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: Atherectomy/Thrombectomy|Percutaneous transluminal removal of thrombotic, thromboembolic and atherothrombotic material from fresh, subacute and chronic occlusions of blood vessels in native blood vessels or vessels fitted with stents, stent grafts or native or artificial bypasses.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major adverse events (MAE) | Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (MAE) Major adverse events Rate | Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb. | 6, 12 and 24 months | 
| Technical success | defined as the ability to cross and treat the target lesion with the Rotarex®S Catheter to achieve residual angiographic stenosis no greater than 50% directly after Rotarex®S Catheter use. | Day 1 | 
| Freedom of Target Lesion Revascularization (TLR) | Freedom of Target Lesion Revascularization (TLR) | 12 Months | 
| Freedom of Target Vessel Revascularization (TVR) | Freedom of Target Vessel Revascularization (TVR) | 1, 6, 12 and 24 Months | 
| Incidence of clinically significant Rotarex®S Catheter -related distal embolization requiring further treatment with pharmacologic or mechanical devices (except treating with intravascular nipride or nitroglycerin). | Rotarex®S Catheter -related distal embolization requiring further treatment with pharmacologic or mechanical devices (except treating with intravascular nipride or nitroglycerin). | From start to end of procedure | 
| Incidence of Rotarex®S Catheter -related perforations. | Rotarex®S Catheter -related perforations. | From start to end of procedure | 
| Clinical success | Defined as clinical category improvement in the Rutherford Class at 1, 6, 12 and 24 months with reference to the baseline value. | 1, 6, 12 and 24 months | 
| Hemodynamic success | Defined as a > 0.15 improvement in ABI (ankle-brachial index) at 30 days with reference to the baseline value. | 30 days | 
| Primary patency at 1, 6, 12 and 24 months. | Defined as freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) < 2.5 in the target vessel with no clinically driven target lesion revascularization (TLR). | 1, 6, 12 and 24 months | 
| Walking improvement at 1, 6, 12 and 24 months assessed by Vascu Quality of Life Questionnaire (VQ-6). | Walking improvement assessed by Vascu Quality of Life Questionnaire (VQ-6) | 1, 6, 12 and 24 months | 
| Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L) | Improvement of quality of life assessed by Questionnaire (EQ5D-3L) | 1, 6, 12 and 24 months | 
| Duration of hospital stay for index procedure [days]. | Number of day from admission to discharge from hospital. | Duration of hospital stay, up to 12 weeks | 
| Duration of ICU stay for index procedure [days]. | Number of day from admission to discharge from intensive care unit. | Duration of ICU stay, up to 12 weeks | 
| Procedural success | Successful revascularization of target lesion defined as ≤30% residual angiographic diameter stenosis following Rotarex®S Catheter treatment ± adjunctive treatment. | From start to end of procedure | 
| Successful use of Arterio Venous-Fistula as dialysis access, defined as successful use of the fistula for dialysis on at least one occasion. | Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter. | Up to 14 days | 
| Number of patients whose hemodialysis is efficient at 1, 6, 12 and 24 months without needing further treatment of the stenotic site after Rotarex®S treatment of the Arterio Venous-Fistula. | Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter. | 1, 6, 12 and 24 months | 
| (SAEs) Serious Adverse events Rate | SAEs as defined per ISO 14155. | 6, 12 and 24 months | 
| Procedure-related Adverse events Rate | Procedure-related AEs as defined per ISO 14155. | 6, 12 and 24 months | 
| (ADEs) Adverse device effects Rate | Adverse device effects (ADEs) as defined per ISO 14155. | 6, 12 and 24 months |