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

Last updated: May 6, 2024
Sponsor: iVascular S.L.U.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

endovascular intervention

Clinical Study ID

NCT05902923
FCRE-220209
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Corresponding to the CE-mark indications/contra-indications and according to the IFUof the device.
  • Patient is >18 years old.
  • Patient understands the nature of the procedure and provides written informed consentprior 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 Catheterand/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug CoatedBalloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral StentSystem and/or the iVolution pro Peripheral Self-Expanding Stent System and/or theiCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheteras described in IFU for each device.

Exclusion

Exclusion Criteria:

  • Anatomy or size of vessels that will not allow appropriate usage of theinvestigational 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 adequatecontraceptives 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.

Study Design

Total Participants: 209
Treatment Group(s): 1
Primary Treatment: endovascular intervention
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • CH Henri Duffaut

    Avignon,
    France

    Site Not Available

  • Clinique Synergia Ventoux

    Carpentras,
    France

    Active - Recruiting

  • Polyclinique Inkermann

    Niort,
    France

    Active - Recruiting

  • L'Hôpital Privé Des Côtes D'Armor

    Plérin,
    France

    Active - Recruiting

  • Hôpital Privé Toulon Hyeres St. Jean

    Toulon,
    France

    Active - Recruiting

  • Hôpital d'instruction des Armées Sainte Anne

    Toulon,
    France

    Active - Recruiting

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