Status:

RECRUITING

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

Lead Sponsor:

iVascular S.L.U.

Conditions:

Artery Disease

Eligibility:

All Genders

18+ years

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...

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.

Key Trial Info

Start Date :

August 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2027

Estimated Enrollment :

209 Patients enrolled

Trial Details

Trial ID

NCT05902923

Start Date

August 1 2023

End Date

August 1 2027

Last Update

May 8 2024

Active Locations (6)

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Page 1 of 2 (6 locations)

1

CH Henri Duffaut

Avignon, France

2

Clinique Synergia Ventoux

Carpentras, France

3

Polyclinique Inkermann

Niort, France

4

L'Hôpital Privé Des Côtes D'Armor

Plérin, France