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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Artery Disease
• Intervention / Treatment: Procedure: endovascular intervention

• Study Type: Observational
• Enrollment (Estimated): 209
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mieke Ramsdonck; Phone Number: +32 479 64 37 60; Email: mieke.ramsdonck@fcre.eu

Study Locations

• France
  • Avignon, France
    • Active, not recruiting
    • CH Henri Duffaut
  • Carpentras, France
    • Recruiting
    • Clinique Synergia Ventoux
    • Contact: Frédéric Verdy
  • Niort, France
    • Recruiting
    • Polyclinique Inkermann
    • Contact: Christophe Marchand
  • Plérin, France
    • Recruiting
    • L'Hôpital Privé Des Côtes D'Armor
    • Contact: Jean-François Desjardins
  • Toulon, France
    • Recruiting
    • Hôpital d'Instruction des Armées Sainte Anne
    • Contact: Fabien Beranger
  • Toulon, France
    • Recruiting
    • Hôpital Privé Toulon Hyeres St. Jean
    • Contact: Pierre Sarradon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Every patient who is eligible for treatment with any of the following devices, can be considered to be included in the study:

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intervention; All patients in the study will undergo same procedure. The implanted devices can be one of more of the study devices.	Procedure: endovascular intervention; endovascular intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedeom from SAEs and SADEs (Primary Safety Endpoint)	Freedeom from SAEs and SADEs	during procedure and up to 2 years after procedure
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Explorative endpoint	Freedom from SAEs and SADEs; Freedom from Target Lesion Revascularization	up to 2 years after procedure

Collaborators and Investigators

• Sponsor: iVascular S.L.U.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FCRE-220209

Drug and device information, study documents

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