Last reviewed · How we verify
NCT05799131: QBX-RADAR
Safety and Efficacy of the QBX Peripheral Balloon Expandable Stent System in Peripheral Artery Disease (PAD)
trial testing QBX (5F/6F) Peripheral Balloon Expandable Stent System in Peripheral Arterial Disease in 100 participants. Status unknown.
30 June 2025
Quick facts
| Lead sponsor | QualiMed Innovative Medizinprodukte GmbH |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 May 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 31 July 2025 |
| Sites | 4 locations across Belgium |
Drugs / interventions tested
- QBX (5F/6F) Peripheral Balloon Expandable Stent System
Conditions studied
- Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
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.
Verify or expand the search:
- PubMed search for NCT05799131
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other QualiMed Innovative Medizinprodukte GmbH trials
Trials by the same sponsor.
- NCT04708288 — A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM, POST MARKET OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND CLINICAL PERFORMANCE · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05799131 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by QualiMed Innovative Medizinprodukte GmbH
- Last refreshed: 5 April 2023
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