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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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