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

NCT05799131 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-04-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • QualiMed Innovative Medizinprodukte GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-06-30
Completion
2025-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05799131 on ClinicalTrials.gov