Clinical trial NCT05902923: Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Artery Disease
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Freedeom from SAEs and SADEs (Primary Safety Endpoint)
timeFrame: during procedure and up to 2 years after procedure
measure: Technical success rate (Primary Efficacy Endpoint)
timeFrame: during procedure
Secondary outcomes:
measure: General physician appraisal of the devices by means of rating scale
timeFrame: during procedure
measure: General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35
timeFrame: during procedure
measure: General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover
timeFrame: during procedure
measure: General physician appraisal of the devices by means of rating scale for the Sergeant
timeFrame: during procedure
measure: Explorative endpoint
timeFrame: up to 2 years after procedure
Other outcomes:
Locations:
city: Avignon
country: France
facility: CH Henri Duffaut
city: Carpentras
country: France
facility: Clinique Synergia Ventoux
city: Niort
country: France
facility: Polyclinique Inkermann
city: Plérin
country: France
facility: L'Hôpital Privé Des Côtes D'Armor
city: Toulon
country: France
facility: Hôpital d'instruction des Armées Sainte Anne
city: Toulon
country: France
facility: Hôpital Privé Toulon Hyeres St. Jean
Study officials:
References: