Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries

NCT05267548 | Unknown

• 1 other identifier: FCRE-211206
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 8

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.

Conditions

Peripheral Arterial Disease Below The Knee

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Freedom from SAE/SADE

  Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) during the procedure and up to 2 years after the procedure (depending on the device that was used).

  2 years

• Primary Efficacy Endpoint: Technical success

  Technical success rate defined as successful crossing, introduction and deployment of 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 according to the respective IFU and without device related deficiencies.

  During procedure

Secondary Outcomes (4)

• Physician Appraisal

  During procedure

• Freedom from SAE

  2 years

• Freedom from SADE

  2 years

• Freedom from TLR

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iVascular S.L.U.: lead
• FCRE (Foundation for Cardiovascular Research and Education): collaborator

Study Sites (8)

Imelda Bonheiden

Bonheiden, Belgium

RECRUITING

Jessa Hasselt

Hasselt, Belgium

RECRUITING

Az Groeninge Kortrijk

Kortrijk, Belgium

RECRUITING

Az Sint Maarten Mechelen

Mechelen, Belgium

RECRUITING

HH Mol

Mol, Belgium

RECRUITING

Az Damiaan Oostende

Ostend, Belgium

RECRUITING

RZ Tienen

Tienen, Belgium

RECRUITING

Az Jan Portaels Vilvoorde

Vilvoorde, Belgium

RECRUITING

Central Study Contacts

Mieke Ramsdonck

CONTACT

mieke.ramsdonck@FCRE.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 4, 2022
• Study Start: May 30, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (8)