Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries

iVascular

Status

Enrolling

Conditions

Artery Disease

Treatments

Procedure: endovascular intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT05902923

FCRE-220209

Details and patient eligibility

About

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.

Enrollment

209 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.