NCT05799131

Safety and Efficacy of the QBX Peripheral Balloon Expandable Stent System in Peripheral Artery Disease (PAD)

QBX (5F/6F) Peripheral Balloon Expandable Stent System for the Treatment of Peripheral Artery Disease (PAD): Assessing Safety and Clinical Performance up to 12-months Follow-up

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: QualiMed Innovative Medizinprodukte GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and performance of the QBX stent system in the treatment of PAD by reporting of peri- and postoperative complications, including major adverse vascular events (MAVE), Vascular Access Site Complications (VASCs) and bleeding at puncture site, and by evaluating the prevalence of Target Vessel Revascularization (TVR), amputations, procedural success, device performance, reduction in percentage diameter stenosis post-procedure compared to pre-procedure, artery patency, return to normal activity, Rutherford and Fontaine classification, quality of life (QoL), Ankle Brachial Index (ABI), and hospital- and patient-related costs in a prospectively maintained database.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	QBX (5F/6F) Peripheral Balloon Expandable Stent System	The QBX Stent System is a flexible, balloon expandable stent, made of a cobalt chromium alloy manufactured by QualiMed Innovative Medizinprodukte GmbH. The design is suitable for peripheral vessel diameters from 5 to 10 mm. The QBX Stent System is available as 6F and 5F variations where the 6F system is mounted on an 0.035" over-the-wire delivery system, and the 5F is mounted on an 0.018" over-the-wire delivery system. Both are available in a full range of diameters and lengths.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-06-30
• Completion: 2025-07-31
• First posted: 2023-04-05
• Last updated: 2023-04-05

Locations

4 sites across 1 country: Belgium