Clinical trial NCT05267548: Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries
Official title: A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter for the Endovascular Intervention in Popliteal and Infrapopliteal Arteries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease Below The Knee
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
Collaborators: name: FCRE (Foundation for Cardiovascular Research and Education)
First posted: 2022-03-04
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this PMCF minimally invasive medical devices with special dedication towards the interventional cardiovascular field will be used. Indications for which the investigational devices are intended are listed in the protocol. Patients will be selected based on the investigator's assessment and evaluation of the underlying disease. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required assessment or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available follow-up.

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 Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.


Eligibility criteria: Inclusion Criteria:

1. Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
2. Patient is \>18 years old.
3. Patient understands the nature of the procedure and provides written informed consent prior to enrolment in the study.
4. Target lesion(s) is/are located in the popliteal or infrapopliteal arteries
5. 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 Criteria:

1. Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
2. Known contraindication and/or allergy to (a component of) an investigational device.
3. Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.
4. Life expectancy of less than 12 months.
5. Any planned surgical intervention/procedure within 30 days after the study procedure.
6. Any patient considered to be hemodynamically unstable at onset of procedure.

Primary outcomes:
measure: Primary Safety Endpoint: Freedom from SAE/SADE
timeFrame: 2 years
measure: Primary Efficacy Endpoint: Technical success
timeFrame: During procedure
Secondary outcomes:
measure: Physician Appraisal
timeFrame: During procedure
measure: Freedom from SAE
timeFrame: 2 years
measure: Freedom from SADE
timeFrame: 2 years
measure: Freedom from TLR
timeFrame: 2 years
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
city: Hasselt
country: Belgium
facility: Jessa Hasselt
city: Kortrijk
country: Belgium
facility: Az Groeninge Kortrijk
city: Mechelen
country: Belgium
facility: Az Sint Maarten Mechelen
city: Mol
country: Belgium
facility: HH Mol
city: Oostende
country: Belgium
facility: Az Damiaan Oostende
city: Tienen
country: Belgium
facility: RZ Tienen
city: Vilvoorde
country: Belgium
facility: Az Jan Portaels Vilvoorde
Study officials:
References: