MAGICAL ISR

Summary

Coronary artery disease (CAD) results from the collection of fat-containing material (plaque) inside a vessel that carries blood to the heart (coronary artery). This makes the vessel narrower (stenosis), decreasing or blocking coronary blood flow and potentially leading to serious consequences, including heart attacks. To open a clogged artery, cardiologists may inflate a drug-coated balloon inside the vessel, to widen it. Then they may place tiny wire-mesh tubes covered with medicine (drug-eluting stents, DES) within the newly reopened vessel, to help keep it open over the long term. However, about 25% of the people treated with DES develop in-stent restenosis (ISR), where plaque or tissue buildup in the stent again narrows or clogs the artery. 

To potentially decrease the chance of repeat coronary stenosis, the MAGICAL ISR study evaluates the safety and efficacy of a sirolimus-coated balloon in the treatment of DES ISR. All participants who join MAGICAL ISR undergo standard treatment to reduce the stenosis through minimally invasive percutaneous coronary intervention. However, they are assigned randomly (50:50, like a coin toss) to receive either the sirolimus-coated balloon or an uncoated balloon. Participants cannot choose or know which group they are assigned to. After the procedure, research team members contact participants for follow-up activities at 30 days, 6 months, and 12 months and then once yearly for a total of 5 years. 

To be included in MAGICAL ISR, participants must be / have

• Adult (18 years or older)
• Suspected ISR of native coronary artery
• Target lesion with visually estimated diameter stenosis of at least 50% but less than 100% in symptomatic patients OR at least 70% or evidence of ischemia in absence of symptoms
• Thrombolysis In Myocardial Infarction (TIMI) grade flow of 1 or greater in target lesion
• Target reference vessel diameter (visual estimation) greater than 2.0 but not larger than 4.0 mm

To be included in MAGICAL ISR, participants must not be / have

• ST-elevation myocardial infarction within 72 hours of presentation to the first treating hospital
• PCI within 24 hours before the index procedure
• Prior treatment of target lesion ISR using drug-coated balloon
• Left ventricular ejection fraction less than 30%
• Target lesion contains a large thrombus, is heavily calcified, or involves chronic total occlusion (or subtotal) without adequate lesion preparation

Keywords
Coronary artery disease; Coronary stenosis, Heart disease; In-stent restenosis