Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries (POP-BTK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease Below The Knee

• Study Type: Observational
• Enrollment (Anticipated): 143

Contacts and Locations

• Study Contact: Name: Mieke Ramsdonck; Email: mieke.ramsdonck@FCRE.eu

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imelda Bonheiden
    • Contact: Dr. Verbist
  • Hasselt, Belgium
    • Recruiting
    • JESSA Hasselt
    • Contact: Dr. Lacquet
  • Kortrijk, Belgium
    • Recruiting
    • AZ Groeninge Kortrijk
    • Contact: Dr. Lerut
  • Mechelen, Belgium
    • Recruiting
    • Az Sint Maarten Mechelen
    • Contact: Dr. Noyéz
  • Mol, Belgium
    • Recruiting
    • HH Mol
    • Contact: Dr. Berghmans
  • Oostende, Belgium
    • Recruiting
    • AZ Damiaan Oostende
    • Contact: Dr. Schepers
  • Tienen, Belgium
    • Recruiting
    • RZ Tienen
    • Contact: Dr. Keirse
  • Vilvoorde, Belgium
    • Recruiting
    • Az Jan Portaels Vilvoorde
    • Contact: Dr. Robijn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Appraisal	General physician appraisal of the devices will be explored based on; Simplicity of handling; Pushability; Trackability; Crossability; Profile Physician appraisal of the Luminor 14m and Luminor 18 Drug Coated Balloon Dilatation Catheters and the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters will be explored based on 1. Deflation time 2. Balloon Compliance 3. Visibility 4. Balloon refolding Physician appraisal for the Angiolite BTK Sirolimus Eluting Peripheral Stent System will be explored based on; Recoil; Radial force; Ease to canalize the lesion; Stent coverage; Stent graft recrossing; Balloon refusal And physician appraisal for the Sergeant Peripheral Support Catheter will be explored based on 1. Trackability over the guide wire 2. Absence of kinking behaviour 3. Injection Capacity 4. Ease of changing guide wires 5. Ease to canalize the lesion	During procedure
Freedom from SAE	Freedom from SAE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used)	2 years
Freedom from SADE	Freedom from SADE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used)	2 years
Freedom from TLR	Freedom from Target Lesion Revascularization post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used), defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FCRE-211206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No