Evaluating the safety and performance of iVascular devices for artery interventions

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.

This study is testing eight different iVascular devices to see how safe and effective they are for people with artery disease in the kidneys, hips, or legs.

Quick facts

• Study type: Observational
• Enrollment: 209 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: iVascular S.L.U. (Industry-sponsored)
• Locations: 6 sites (Avignon and 5 other locations)
• Trial ID: NCT05902923 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and clinical performance of eight different iVascular devices used for endovascular interventions in patients with artery disease affecting the renal, iliac, or femoral arteries. It will involve a real-world population of 209 patients who have undergone these interventions as part of standard care. The study will collect data on the outcomes and effectiveness of the devices to confirm their safety and performance in clinical practice.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with lesions in the renal, iliac, or femoral arteries who meet the device-specific eligibility criteria.

Not a fit: Patients with anatomical or vessel size limitations that prevent the use of the investigational devices will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of endovascular treatments for patients with artery disease.

How similar studies have performed: Other studies have shown success with similar endovascular interventions, indicating a promising approach for this patient population.

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.

Where this trial is running

Avignon and 5 other locations

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

Study contacts

• Study coordinator: Mieke Ramsdonck

Conditions Artery Disease