MAGICAL SV

Summary

Small-vessel coronary artery disease (CAD) is where the tiny, branching blood vessels in the heart walls are damaged or fail to open correctly. A common, minimally invasive treatment (percutaneous coronary intervention, PCI) for small-vessel CAD is to use a little balloon to open these narrowed arteries and restore blood flow. Sometimes the balloon is coated with medication. This medicine remains in the treated blood vessel to help keep it from closing again.  

The MAGICAL SV study evaluates the safety and efficacy of a sirolimus-coated balloon in treatment of small-vessel CAD. In the study, patients with small-vessel CAD who are scheduled for PCI are randomly assigned (50:50; like tossing a coin) to receive either the sirolimus-coated balloon or one that does not have sirolimus. Neither the lead investigator nor the study participant can choose which treatment they receive. Participants in MAGICAL SV have a physical exam and medical record review within 7 days after PCI. Research team members perform various study follow-up tasks at 30 days, 6 months, and 12 months after the procedure. 

To be included in MAGICAL SV, patients must be / have

• Adults (at least 18 years of age but younger than 80 years)  
• Eligible for PCI due to stable angina, post-infarction angina, or silent ischemia  
• Maximum of 2 small-vessel target lesions in 2 different vessels  

To be included in MAGICAL SV, patients must not be / have

• Acute cardiac decompensation or cardiogenic shock  
• ST-segment elevation myocardial infarction within 48 hours before the procedure  
• Impaired kidney function (glomerular filtration rate below 30 mL/min)  
• Cerebrovascular accident (CVA, stoke) within 3 months prior to the procedure or permanent neurologic defect due to CVA  

Keywords
Cardiovascular disease; Coronary artery disease; Coronary artery stenosis; Coronary microvascular disease; Small vessel disease