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European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.

NCT04743180 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-02-11

No results posted yet for this study

Summary

The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.

Conditions

  • Angioplasty
  • Peripheral Arterial Disease
  • Drug-eluting Balloon
  • Femoral Artery
  • Paclitaxel

Interventions

DEVICE

LUMINOR© Paclitaxel eluting balloon

Patients will be treated with the Luminor paclitaxel eluting balloon

Sponsors & Collaborators

  • iVascular S.L.U.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2022-06-30
Completion
2026-06-30

Countries

  • France

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 NCT04743180 on ClinicalTrials.gov