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.

iVascular S.L.U.6 sites in 1 country209 target enrollmentAugust 1, 2023

ConditionsArtery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Artery Disease
Sponsor: iVascular S.L.U.
Enrollment: 209
Locations: 6
Primary Endpoint: Technical success rate (Primary Efficacy Endpoint)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

August 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

iVascular S.L.U.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Technical success rate (Primary Efficacy Endpoint)

Time Frame: during procedure

Technical success rate defined as ability to cross, introduce and deploy devices based on quantitative scaling by investigators

Freedeom from SAEs and SADEs (Primary Safety Endpoint)

Time Frame: during procedure and up to 2 years after procedure

Freedeom from SAEs and SADEs

Secondary Outcomes

General physician appraisal of the devices by means of rating scale for the Sergeant(during procedure)
General physician appraisal of the devices by means of rating scale(during procedure)
Explorative endpoint(up to 2 years after procedure)
General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35(during procedure)
General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover(during procedure)