Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries

Study Overview
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Brief Summary
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The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.

Official Title
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A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.

Conditions
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Artery Disease

Intervention / Treatment
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* Procedure: endovascular intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device. Patient is >18 years old. Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study. Target lesion(s) is/are located in renal, iliac or femoral arteries. Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in IFU for each device. Exclusion Criteria: Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices. Known contraindication and/or allergy to (a component of) an investigational device. Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding. Life expectancy of less than 12 months. Any planned surgical intervention/procedure within 30 days after the study procedure. Any patient considered to be hemodynamically unstable at onset of the procedure.

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intervention<br>All patients in the study will undergo same procedure. The implanted devices can be one of more of the study devices. | Procedure: endovascular intervention<br>* endovascular intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedeom from SAEs and SADEs (Primary Safety Endpoint) | Freedeom from SAEs and SADEs | during procedure and up to 2 years after procedure | 
| Technical success rate (Primary Efficacy Endpoint) | Technical success rate defined as crossing, introduction and deployment of devices | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General physician appraisal of the devices by means of rating scale | General physician appraisal of the devices will be explored based on: 1. Simplicity of handling, 2. Pushability, 3. Trackability, 4. Crossability and 5. Profile | during procedure | 
| General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35 | Physician appraisal for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35 will be explored based on: 1. Deflation time, 2. Balloon Compliance, 3. Visibility and 4. Balloon refolding | during procedure | 
| General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover | Physician appraisal for the Restorer, iVolution pro, iCover be explored based on: 1. Recoil, 2. Radial force, 3. Ease to canalize the lesion, 4. Stent coverage, 5. Stent graft recrossing and 6. Balloon refusal | during procedure | 
| General physician appraisal of the devices by means of rating scale for the Sergeant | And physician appraisal for the Sergeant will be explored based on: 1. Trackability over the guide wire, 2. Absence of kinking behaviour, 3. Injection Capacity, 4. Ease of changing guide wires and 5. Ease to canalize the lesion | during procedure | 
| Explorative endpoint | Freedom from SAEs and SADEs; Freedom from Target Lesion Revascularization | up to 2 years after procedure |