BIOFLOW-china Post-marketing Study (BIOTRONIK)

TerminatedOBSERVATIONAL
Enrollment

122

Participants

Timeline

Start Date

June 2, 2023

Primary Completion Date

September 27, 2024

Study Completion Date

September 27, 2024

Conditions
In-Stent Stenosis (Restenosis) of Coronary Artery StentNative 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."

Trial Locations (2)

150001

The 4th Affiliated Hospital of Harbin Medical University, Harbin

310000

Zhejiang University Mingzhou Hospital, Ningbo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biotronik AG

INDUSTRY

lead

Biotronik (Beijing) Medical Device Ltd.

INDUSTRY

NCT05667285 - BIOFLOW-china Post-marketing Study (BIOTRONIK) | Biotech Hunter | Biotech Hunter