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USM Lastest News

22/03/2018

XPLOSION™ Sirolimus Coronary Stent Clinical Trial Results

XPLOSION™ Sirolimus Stent

 

Ho Chi Minh City – USM Healthcare, in collaboration with Cho Ray Hospital, proud to announce the results of XPOSION Sirolimus Eluting Coronary Stent clinical trial. XPLOSION is the first drug eluting coronary stent made in Vietnam. Sirolimus Drug Eluting stent (DES) are used for the treatment of arteriosclerosis which is used to remove the cholesterol deposited on the artery wall and prevent the carcinogenicity by releasing anti-proliferative drug.

The objective of the clinical trial is to evaluate the Safety and Effectiveness of the Sirolimus Eluting Stent System during and after 6 months Percutaneous Coronary Intervention (PCI) in patients with stable ischemic heart disease. To determine the Rate of Procedural Success of stent implantation. The clinical trial compared the Grading of Angina Pectoris (According to CSS: Canadian Cardiovascular Society) before and after stent implantation at study time points. In addition, it determined the frequency and level of Adverse Events and Serious Adverse Events (AE/SAE) at study time points.

40 patients over the age of 18 years old, with stable ischemic heart disease, were followed after 6 months after implentation of XPLOSION. After stent implantation, the patients take the drugs as per routine regimen, Clinical follow-ups at 30 days an 180 days, and DSA procedure at D180.

The results of 6 months clinical trials were:

1) Implantation of the first Sirolimus Eluting Coronary Stent System made in Vietnam by technology transferred from the United States has been carried out conveniently and safely in patients with 100% clinical and procedural success after intervention.

2) 6 month follow-up result: no in-stent restenosis, no in-stent thrombosis, as well as no cardiac death or myocardial infarction.

USM Healthcare and Cho Ray Hospital will continue clinical study on those treated patients in 12 months and 24 months. 

 

 XPLOSION™ Stent at 250x Magnification XPLOSION Stent at 250x Magnification

 

XPLOSION™ Stent at 500x MagnificationXPLOSION™ Stent at 500x Magnification 

 

XPLOSION+ Stent Results

XPLOSION Stent results no MACE after 6 months 

  

XPLOSION™ Concept Art

XPLOSION, first stent made in Vietnam

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