Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries

Artery Disease Clinical Trial

Official title:

A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902923
• Other study ID #: FCRE-220209
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: August 2027

Study information

• Verified date: May 2024
• Source: iVascular S.L.U.
• Contact: Mieke Ramsdonck
• Phone: +32 479 64 37 60
• Email: mieke.ramsdonck[@]fcre.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 209
• Est. completion date: August 2027
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 enrollment in the study.

• Target lesion(s) is/are located in renal, iliac or femoral arteries.

• Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in IFU for each device.

Exclusion Criteria:

• 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 the procedure.

Related Conditions & MeSH terms

• Artery Disease

Intervention

Procedure:
• endovascular intervention
endovascular intervention

Locations

Country	Name	City	State
France	CH Henri Duffaut	Avignon
France	Clinique Synergia Ventoux	Carpentras
France	Polyclinique Inkermann	Niort
France	L'Hôpital Privé Des Côtes D'Armor	Plérin
France	Hôpital d'instruction des Armées Sainte Anne	Toulon
France	Hôpital Privé Toulon Hyeres St. Jean	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
iVascular S.L.U.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedeom from SAEs and SADEs (Primary Safety Endpoint)	Freedeom from SAEs and SADEs	during procedure and up to 2 years after procedure
Primary	Technical success rate (Primary Efficacy Endpoint)	Technical success rate defined as ability to cross, introduce and deploy devices based on quantitative scaling by investigators	during procedure
Secondary	General physician appraisal of the devices by means of rating scale	General physician appraisal of the devices will be explored based on: 1. Simplicity of handling, 2. Pushability, 3. Trackability, 4. Crossability and 5. Profile	during procedure
Secondary	General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35	Physician appraisal for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35 will be explored based on: 1. Deflation time, 2. Balloon Compliance, 3. Visibility and 4. Balloon refolding	during procedure
Secondary	General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover	Physician appraisal for the Restorer, iVolution pro, iCover be explored based on: 1. Recoil, 2. Radial force, 3. Ease to canalize the lesion, 4. Stent coverage, 5. Stent graft recrossing and 6. Balloon refusal	during procedure
Secondary	General physician appraisal of the devices by means of rating scale for the Sergeant	And physician appraisal for the Sergeant 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 and 5. Ease to canalize the lesion	during procedure
Secondary	Explorative endpoint	Freedom from SAEs and SADEs; Freedom from Target Lesion Revascularization	up to 2 years after procedure