BIOFLOW-china Post-marketing Study (BIOTRONIK)

Native Coronary Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05667285
• Other study ID #: C2022
• Status: Enrolling by invitation
• Start date: May 26, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: August 2023
• Source: Biotronik (Beijing) Medical Device Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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-upafter 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject should be 18 years or older when undergoing the procedure;
• Subjects sign informed consent;
• The subject signed informed consent dated back within 12 months and only 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 ;
• Has undergone PCI without a study stent implantation;
• 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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Stenosis
• Native Coronary Artery Stenosis

Intervention

Device:
• BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
The investigator will use visual inspection or QCA to assess the diameter of the artery and the length of the lesion during the operation to select the stent. For each lesion, the investigator will determine the number of stents to be used based on the actual situation. The length of the stent should cover from the proximal end of the normal reference vessel to the distal end of the normal reference vessel to ensure full coverage of the lesion. For each lesion, the investigator will determine the number of stents to be used based on the actual situation. A second stent or more stents can be used when the first stent does not completely cover the lesion. In this case, the second stent or even more stents must be this investigational stent, unless it is clinically contraindicated. Please refer to the IFU operating procedure of the stent. If the stents are placed overlappingly, the overlapping part should be at least 2 mm.

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik (Beijing) Medical Device Ltd.	Biotronik AG

Country where clinical trial is conducted

China, 

References & Publications (4)

Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-ma — View Citation

Kandzari DE, Koolen JJ, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R; BIOFLOW V Investigators. Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary R — View Citation

Li C, Yang Y, Han Y, Song D, Xu J, Guan C, Gao R, Garcia-Garcia HM, Waksman R, Xu B; BIOFLOW VI Trial Investigators. Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chin — View Citation

Saito S, Toelg R, Witzenbichler B, Haude M, Masotti M, Salmeron R, Witkowski A, Uematsu M, Takahashi A, Waksman R, Slagboom T. BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-elu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure (TLF) at 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	Major adverse cardiac event (MACE) at 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
Secondary	Target lesion failure (TLF) at 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
Secondary	Serious adverse device effects (SADEs)	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