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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriVascular S.L.U.

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • endovascular intervention

Treatment groups

209 Participants
are divided into 1 treatment group

Sponsors and collaborators