Artery Disease
Conditions
Brief summary
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.
Interventions
PROCEDUREendovascular intervention
endovascular intervention
Sponsors
iVascular S.L.U.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedeom from SAEs and SADEs (Primary Safety Endpoint) | during procedure and up to 2 years after procedure | Freedeom from SAEs and SADEs |
| Technical success rate (Primary Efficacy Endpoint) | during procedure | Technical success rate defined as ability to cross, introduce and deploy devices based on quantitative scaling by investigators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover | during procedure | 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 |
| General physician appraisal of the devices by means of rating scale | during procedure | General physician appraisal of the devices will be explored based on: 1. Simplicity of handling, 2. Pushability, 3. Trackability, 4. Crossability and 5. Profile |
| Explorative endpoint | up to 2 years after procedure | Freedom from SAEs and SADEs; Freedom from Target Lesion Revascularization |
| General physician appraisal of the devices by means of rating scale for the Sergeant | during procedure | 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 |
| General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35 | during procedure | 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 |
Countries
France
Contacts
Primary ContactMieke Ramsdonck
Outcome results
None listed