Evaluating the safety and performance of iVascular devices for artery interventions
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.
Run by iVascular S.L.U. · NCT05902923 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 209 (estimated) |
| Sponsor | iVascular S.L.U. Industry-sponsored |
| Locations | 6 sites (Avignon and 5 other locations) |
| Status | Recruiting |
| Started | August 1, 2023 |
| Main results expected | August 2025 |
| Study ends | August 2027 |
| Registry record updated | May 8, 2024 |
| Trial ID | NCT05902923 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with anatomical or vessel size limitations that prevent the use of the investigational devices will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with similar endovascular interventions, indicating a promising approach for this patient population.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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 -
CH Henri Duffaut
Avignon, France Active not recruiting
Study contacts
- Study coordinator: Mieke Ramsdonck
- Email: mieke.ramsdonck@fcre.eu
- Phone: +32 479 64 37 60
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using music therapy to help patients with lower limb artery disease
This study tests whether a music therapy walking program can help people with lower limb artery disease walk better and improve their overall health.
-
iCover covered stents used as bridging stents during fenestrated endovascular repair for complex abdominal aortic aneurysms
This trial will test whether the iCover balloon-expandable covered stent works safely and reliably as a bridging stent to connect renal and other visceral arteries during fenestrated endovascular repair in people with complex abdominal aortic aneurysms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.