Last updated: February 1, 2023
Sponsor: iVascular S.L.U.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Peripheral Arterial Occlusive Disease
Circulation Disorders
Claudication
Treatment
N/AClinical Study ID
NCT05267548
FCRE-211206
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 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 theOceanus 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 ElutingPeripheral Stent System and/or the Sergeant Peripheral Support Catheter as describedin the 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 procedure.
Study Design
Total Participants: 143
Study Start date:
May 30, 2022
Estimated Completion Date:
May 31, 2025
Connect with a study center
Imelda Bonheiden
Bonheiden,
BelgiumActive - Recruiting
Jessa Hasselt
Hasselt,
BelgiumActive - Recruiting
Az Groeninge Kortrijk
Kortrijk,
BelgiumActive - Recruiting
Az Sint Maarten Mechelen
Mechelen,
BelgiumActive - Recruiting
HH Mol
Mol,
BelgiumActive - Recruiting
Az Damiaan Oostende
Oostende,
BelgiumActive - Recruiting
RZ Tienen
Tienen,
BelgiumActive - Recruiting
Az Jan Portaels Vilvoorde
Vilvoorde,
BelgiumActive - Recruiting
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