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NCT Number: NCT05902923

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

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.

Recruiting

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Key information

Conditions

Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Henri Duffaut, Avignon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endovascular intervention

Procedure

endovascular intervention

Primary outcomes

  1. Freedeom from SAEs and SADEs (Primary Safety Endpoint)

    Time frame: during procedure and up to 2 years after procedure

    Freedeom from SAEs and SADEs

  2. Technical success rate (Primary Efficacy Endpoint)

    Time frame: during procedure

    Technical success rate defined as ability to cross, introduce and deploy devices based on quantitative scaling by investigators

Secondary outcomes

  1. General physician appraisal of the devices by means of rating scale

    Time frame: during procedure

    General physician appraisal of the devices will be explored based on: 1. Simplicity of handling, 2. Pushability, 3. Trackability, 4. Crossability and 5. Profile

  2. General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35

    Time frame: during procedure

    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

  3. General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover

    Time frame: during procedure

    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

  4. General physician appraisal of the devices by means of rating scale for the Sergeant

    Time frame: during procedure

    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

  5. Explorative endpoint

    Time frame: up to 2 years after procedure

    Freedom from SAEs and SADEs; Freedom from Target Lesion Revascularization

Study contacts

Contact information is provided by the study sponsor or research team.

Mieke Ramsdonck

CONTACT

[email protected]

+32 479 64 37 60

Sponsors and collaborators

Lead sponsor

iVascular S.L.U.

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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