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

Recruiting

• Conditions: Peripheral Arterial Disease Below The Knee

• Registration Number: NCT05267548
• Lead Sponsor: iVascular S.L.U.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-04
• Study Start: 2022-05-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Technical success	During procedure	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.
Primary Safety Endpoint: Freedom from SAE/SADE	2 years	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).

Secondary Outcome Measures

Name	Time	Method
Physician Appraisal	During procedure	General physician appraisal of the devices will be explored based on; 1. Simplicity of handling; 2. Pushability; 3. Trackability; 4. Crossability; 5. 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; 1. Recoil; 2. Radial force; 3. Ease to canalize the lesion; 4. Stent coverage; 5. Stent graft recrossing; 6. 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
Freedom from SAE	2 years	Freedom from SAE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used)
Freedom from SADE	2 years	Freedom from SADE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used)
Freedom from TLR	2 years	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.

Trial Locations

Locations (8)

Jessa Hasselt; 🇧🇪 Hasselt, Belgium

Az Jan Portaels Vilvoorde; 🇧🇪 Vilvoorde, Belgium

Az Sint Maarten Mechelen; 🇧🇪 Mechelen, Belgium

Az Damiaan Oostende; 🇧🇪 Oostende, Belgium

Imelda Bonheiden; 🇧🇪 Bonheiden, Belgium

Az Groeninge Kortrijk; 🇧🇪 Kortrijk, Belgium

HH Mol; 🇧🇪 Mol, Belgium

RZ Tienen; 🇧🇪 Tienen, Belgium