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BIOFLOW-china Post-marketing Study (BIOTRONIK)

NCT05667285 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2024-12-16

No results posted yet for this study

Summary

This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.

The goal of this study is to assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China.

Conditions

  • In-Stent Stenosis (Restenosis) of Coronary Artery Stent
  • Native Coronary Artery Stenosis

Interventions

DEVICE

BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System

During the procedure, the investigator assesses the arterial diameter and lesion length either visually or using QCA to select the appropriate stent. The number of stents required for each lesion is determined by the investigator based on the specific circumstances. The length of the stent should cover from the proximal normal reference vessel to the distal normal reference vessel, ensuring complete coverage of the lesion. The number of stents required for each lesion is determined by the investigator based on the specific circumstances. If the first stent does not fully cover the lesion, a second or even more stents may be used. In such cases, the second or additional stents are selected by the investigator based on the specific circumstances, such as using Orsiro SES stents, unless clinically contraindicated or specifically required. Please refer to the stent's Instructions for Use for the procedure. If stent overlap occurs, the overlapping part should be at least 2mm.

Sponsors & Collaborators

  • Biotronik AG

    collaborator INDUSTRY

  • Biotronik (Beijing) Medical Device Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Yang · The Fourth Affiliated Hospital of Harbin Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2024-09-27
Completion
2024-09-27

Countries

  • China

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 NCT05667285 on ClinicalTrials.gov