Status:
UNKNOWN
Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries
Lead Sponsor:
iVascular S.L.U.
Collaborating Sponsors:
FCRE (Foundation for Cardiovascular Research and Education)
Conditions:
Peripheral Arterial Disease Below The Knee
Eligibility:
All Genders
18+ years
Brief Summary
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated ...
Eligibility Criteria
Inclusion
- 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 enrolment in the study.
- Target lesion(s) is/are located in the popliteal or infrapopliteal arteries
- Patient is eligible for treatment with the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in the IFU for each device.
Exclusion
- 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 procedure.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT05267548
Start Date
May 30 2022
End Date
May 1 2025
Last Update
February 3 2023
Active Locations (8)
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1
Imelda Bonheiden
Bonheiden, Belgium
2
Jessa Hasselt
Hasselt, Belgium
3
Az Groeninge Kortrijk
Kortrijk, Belgium
4
Az Sint Maarten Mechelen
Mechelen, Belgium