NCT05902923

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

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 209 (estimated)
• Sponsor: iVascular S.L.U. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Artery Disease

Interventions

Type	Name	Description
PROCEDURE	endovascular intervention	endovascular intervention

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-08-01
• Completion: 2027-08-01
• First posted: 2023-06-15
• Last updated: 2024-05-08

Locations

6 sites across 1 country: France