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

Recruiting now

Conditions studied: Artery Disease

In brief

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.

Key facts

Study ID

NCT05902923

Run by

iVascular S.L.U.

People needed

209

Starts

2023-08-01

Expected to finish

2027-08-01

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinique Synergia Ventoux — Carpentras, France (enrolling)
• Polyclinique Inkermann — Niort, France (enrolling)
• L'Hôpital Privé Des Côtes D'Armor — Plérin, France (enrolling)
• Hôpital d'instruction des Armées Sainte Anne — Toulon, France (enrolling)
• Hôpital Privé Toulon Hyeres St. Jean — Toulon, France (enrolling)
• CH Henri Duffaut — Avignon, France

Full record on ClinicalTrials.gov

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