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Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
Sponsor: iVascular S.L.U.
Summary
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.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
209
Start Date
2023-08-01
Completion Date
2027-08
Last Updated
2024-05-08
Healthy Volunteers
No
Conditions
Interventions
endovascular intervention
endovascular intervention
Locations (6)
CH Henri Duffaut
Avignon, France
Clinique Synergia Ventoux
Carpentras, France
Polyclinique Inkermann
Niort, France
L'Hôpital Privé Des Côtes D'Armor
Plérin, France
Hôpital d'instruction des Armées Sainte Anne
Toulon, France
Hôpital Privé Toulon Hyeres St. Jean
Toulon, France