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NCT05799131: QBX-RADAR

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

Status unknown Last updated 5 April 2023
What this trial tests

trial testing QBX (5F/6F) Peripheral Balloon Expandable Stent System in Peripheral Arterial Disease in 100 participants. Status unknown.

Timeline
1 May 2023
Primary endpoint
30 June 2025
31 July 2025

Quick facts

Lead sponsorQualiMed Innovative Medizinprodukte GmbH
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date1 May 2023
Primary completion30 June 2025
Estimated completion31 July 2025
Sites4 locations across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

QualiMed Innovative Medizinprodukte GmbH

Who can join

18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Peripheral Arterial Disease

Currently open trials in the same condition.

Other QualiMed Innovative Medizinprodukte GmbH trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05799131.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing