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.
Study Type
OBSERVATIONAL
Enrollment
209
endovascular intervention
CH Henri Duffaut
Avignon, France
ACTIVE_NOT_RECRUITINGClinique Synergia Ventoux
Carpentras, France
RECRUITINGPolyclinique Inkermann
Niort, France
RECRUITINGFreedeom from SAEs and SADEs (Primary Safety Endpoint)
Freedeom from SAEs and SADEs
Time frame: 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
Time frame: during procedure
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
Time frame: 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
Time frame: 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
Time frame: 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
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L'Hôpital Privé Des Côtes D'Armor
Plérin, France
RECRUITINGHôpital d'instruction des Armées Sainte Anne
Toulon, France
RECRUITINGHôpital Privé Toulon Hyeres St. Jean
Toulon, France
RECRUITINGTime frame: during procedure
Explorative endpoint
Freedom from SAEs and SADEs; Freedom from Target Lesion Revascularization
Time frame: up to 2 years after procedure