BIOFLOW-china Post-marketing Study (BIOTRONIK) (BIOFLOW-China)

December 11, 2024 updated by: Biotronik (Beijing) Medical Device Ltd.

Chinese Post-marketing Clinical Study Project Protocol for Evaluate the Safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods. A total of 2,000 subjects will be enrolled from up to 15 research sites in China. Suitable subjects will be selected according to the inclusion and exclusion criteria, and those who meet the inclusion and exclusion criteria will accept follow-up after signing the informed consent form from the site ethics committee until 5 years after surgery. It is aimed to further assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China by observing the data collected in this trial.

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The 4th Affiliated Hospital of Harbin Medical University
    • Zhejiang
      • Ningbo, Zhejiang, China, 310000
        • Zhejiang University Mingzhou Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The Sirolimus-eluting coronary stent system can improve the diameter of the coronary lumen. It is suitable for patients with ischemic heart disease symptoms caused by primary stenotic lesions and in-stent restenotic lesions (length ≤ 36 mm) dispersed within the native coronary arteries (reference vessel diameter of 2.25 mm to 4.0 mm).

Description

Inclusion Criteria:

  • The subject should be 18 years or older when undergoing the procedure.
  • The subject has signed the Informed Consent.
  • The subject signed Informed Consent dated back within 12 months and was implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.

Exclusion Criteria:

  • The subject has or had a life expectancy less then 12 month after treatment with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
  • The subject has any known allergies to the following substances: aspirin, heparin/divalerythromycin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), bivalirudin, rapamycin, L-605 cobalt-chromium (Co-Cr) alloy or its main elements (cobalt, chromium, tungsten and nickel), acrylic acid, fluoropolymer, silicon carbide, PLLA allergy or contraindications.
  • The investigator judges that the subject has poor compliance and cannot complete the study as required, or other circumstances that are not suitable for participation in this study .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
Subject implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure (TLF) at 1 years ± 60 days after surgery
Time Frame: 1 years ± 60 days after surgery
Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).
1 years ± 60 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac event (MACE) at 1, 2, 3, 4 and 5 years ± 60 days after surgery
Time Frame: 1, 2, 3, 4 and 5 years ± 60 days after surgery
Including all-cause deaths, Q-wave or non-Q-wave myocardial infarction, and clinically driven target lesion revascularizition (TLR).
1, 2, 3, 4 and 5 years ± 60 days after surgery
Target lesion failure (TLF) at 2, 3, 4 and 5 years ± 60 days after surgery
Time Frame: 2, 3, 4 and 5 years ± 60 days after surgery
Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).
2, 3, 4 and 5 years ± 60 days after surgery
Serious adverse device effects (SADEs)
Time Frame: 1, 2, 3, 4 and 5 years ± 60 days after surgery
A serious adverse device effect (SADE) refers to any adverse device event that leads to the consequences and characteristics of serious adverse events.
1, 2, 3, 4 and 5 years ± 60 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik (Beijing) Medical Device Ltd.

Collaborators

Biotronik AG

Investigators

  • Principal Investigator: Wei Yang, The Fourth Affiliated Hospital of Harbin Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2023

Primary Completion (Actual)

September 27, 2024

Study Completion (Actual)

September 27, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sponsor has exclusive ownership of the trial data and results. During the clinical trial process, the sponsor has the right to consult and use all the data and results obtained from the trial. Before the results of each site are published and/or reported, any single clinical trial site is not allowed to publish and/or report its results. The sponsor agrees that the principal investigator of the trial may publish the results of the clinical trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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