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BIOLUX P-III BENELUX All-Comers Registry

NCT03052309 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2022-08-15

No results posted yet for this study

Summary

The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Passeo-18 Lux DCB

The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU)

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Franck Vermassen · UZ Gent

  • JGAM Blomjous · OLVG Amsterdam

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2020-06-09
Completion
2021-04-27

Countries

  • Belgium
  • Luxembourg
  • Netherlands

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 NCT03052309 on ClinicalTrials.gov