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Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)

NCT02460042 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 960

Last updated 2025-02-11

No results posted yet for this study

Summary

The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

PROCEDURE

drug coated balloon angioplasty

percutaneous transluminal angioplasty with peripheral balloon catheters

DEVICE

SeQuent® Please OTW Paclitaxel Coated Balloon Catheter

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Ralf Langhoff, MD · St. Gertrauden Krankenhaus, Berlin, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-12-31
Completion
2025-12-31

Countries

  • Germany

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 NCT02460042 on ClinicalTrials.gov