Last updated: May 6, 2024
Sponsor: iVascular S.L.U.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
endovascular intervention
Clinical Study ID
NCT05902923
FCRE-220209
Ages > 18 All Genders
Study Summary
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,
FranceSite Not Available
Clinique Synergia Ventoux
Carpentras,
FranceActive - Recruiting
Polyclinique Inkermann
Niort,
FranceActive - Recruiting
L'Hôpital Privé Des Côtes D'Armor
Plérin,
FranceActive - Recruiting
Hôpital Privé Toulon Hyeres St. Jean
Toulon,
FranceActive - Recruiting
Hôpital d'instruction des Armées Sainte Anne
Toulon,
FranceActive - Recruiting

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