Clinical trial NCT05667285: BIOFLOW-china Post-marketing Study (BIOTRONIK)
Official title: Chinese Post-marketing Clinical Study Project Protocol for Evaluate the Safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: In-Stent Stenosis (Restenosis) of Coronary Artery Stent
Native Coronary Artery Stenosis
Keywords: Orsiro
BIOTRONIK
China
Coronary Stent System
Lead sponsor: Biotronik (Beijing) Medical Device Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Biotronik AG
First posted: 2022-12-28
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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).

Brief 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.

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Target lesion failure (TLF) at 1 years ± 60 days after surgery
timeFrame: 1 years ± 60 days after surgery
Secondary outcomes:
measure: Major adverse cardiac event (MACE) at 1, 2, 3, 4 and 5 years ± 60 days after surgery
timeFrame: 1, 2, 3, 4 and 5 years ± 60 days after surgery
measure: Target lesion failure (TLF) at 2, 3, 4 and 5 years ± 60 days after surgery
timeFrame: 2, 3, 4 and 5 years ± 60 days after surgery
measure: Serious adverse device effects (SADEs)
timeFrame: 1, 2, 3, 4 and 5 years ± 60 days after surgery
Other outcomes:
Locations:
city: Harbin
country: China
facility: The 4th Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Ningbo
country: China
facility: Zhejiang University Mingzhou Hospital
state: Zhejiang
Study officials:
affiliation: The Fourth Affiliated Hospital of Harbin Medical University
name: Wei Yang
role: PRINCIPAL_INVESTIGATOR
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