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Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

NCT02554292 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 481

Last updated 2020-03-30

No results posted yet for this study

Summary

The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DEVICE

Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation

Percutaneous Coronary Intervention

Sponsors & Collaborators

  • Ernst von Bergmann Hospital

    collaborator OTHER

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Klaus Bonaventura, MD · Klinikum Ernst von Bergmann

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-12-31
Completion
2019-12-31

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 NCT02554292 on ClinicalTrials.gov