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Recruiting NCT05902923

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

— Observational Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endovascular intervention.
Who it may be relevant to
Registry conditions: Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Procedure endovascular intervention
    endovascular intervention

Primary outcome measures

  • Freedeom from SAEs and SADEs (Primary Safety Endpoint) [Time frame: during procedure and up to 2 years after procedure]
  • Technical success rate (Primary Efficacy Endpoint) [Time frame: during procedure]
Secondary outcome measures (5)
  • General physician appraisal of the devices by means of rating scale [Time frame: during procedure]
  • 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]
  • General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover [Time frame: during procedure]
  • General physician appraisal of the devices by means of rating scale for the Sergeant [Time frame: during procedure]
  • Explorative endpoint [Time frame: up to 2 years after procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 6 centers
  • CH Henri Duffaut — Avignon
  • Clinique Synergia Ventoux — Carpentras
  • Polyclinique Inkermann — Niort
  • L'Hôpital Privé Des Côtes D'Armor — Plérin
  • Hôpital d'instruction des Armées Sainte Anne — Toulon
  • Hôpital Privé Toulon Hyeres St. Jean — Toulon

Identifiers

NCT: NCT05902923 · FCRE-220209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗