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Novel side branch ostial stent (BIGUARD): first-in-man study
Shao-liang Chen1, Jun-jie Zhang, Fei Ye
1Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China. chmengx@126.com
Chinese Medical Journal
|September 29, 2009
Summary
The novel BIGUARD stent demonstrated safety and feasibility for treating complex coronary bifurcation lesions in a Chinese study. Clinical outcomes at 12 months showed low rates of major adverse cardiac events and target lesion revascularization.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Coronary artery stenting in bifurcation lesions presents significant technical challenges.
- Limited data exists on dedicated bifurcation stent outcomes in China.
- The BIGUARD stent is a novel device designed for side branch ostial stenting.
Purpose of the Study:
- To evaluate the safety and clinical outcomes of the BIGUARD stent in treating coronary bifurcation lesions.
- To assess the performance of a new dedicated bifurcation stent in a real-world clinical setting.
Main Methods:
- A first-in-man study enrolled 47 patients with coronary bifurcation lesions.
- The study included patients with true bifurcation lesions and diabetes.
- A 12-month follow-up assessed major adverse cardiac events (MACE), including clinical and angiographic data.
Main Results:
- The in-hospital MACE rate was 2%, with one non-ST segment elevation myocardial infarction.
- At 12 months, target lesion revascularization was 8.6% and composite MACE was 10.6%.
- No cardiac death or stent thrombosis occurred; restenosis rates were 9.4% (main vessel) and 2.1% (side branch ostium).
Conclusions:
- The BIGUARD stent proved to be safe and feasible for treating coronary bifurcation lesions.
- The study supports the use of this dedicated stent in complex coronary interventions.
