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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | All patients in the study will undergo same procedure. The implanted devices can be one of more of the study devices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular intervention | Procedure | endovascular intervention |
|
| 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 ability to cross, introduce and deploy devices based on quantitative scaling by investigators | during procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Every patient who is eligible for treatment with any of the following devices, can be considered to be included in the study:
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mieke Ramsdonck | Contact | +32 479 64 37 60 | mieke.ramsdonck@fcre.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Henri Duffaut | Active, not recruiting | Avignon | France | |||
| Clinique Synergia Ventoux |
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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 |
| Recruiting |
| Carpentras |
| France |
|
| Polyclinique Inkermann | Recruiting | Niort | France |
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| L'Hôpital Privé Des Côtes D'Armor | Recruiting | Plérin | France |
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| Hôpital d'instruction des Armées Sainte Anne | Recruiting | Toulon | France |
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| Hôpital Privé Toulon Hyeres St. Jean | Recruiting | Toulon | France |
|