Magic-Touch™ Sirolimus-Coated Balloon for treatment in Coronary Artery Lesions of In-Stent Restenosis – “Magical ISR Study”

The purpose of this study is to compare the efficacy (how well it works) and safety of the MagicTouchTM Sirolimus-Coated Balloon in addition to POBA compared to POBA alone (standard of care), in patients with restenosis of previously placed DES.

Often times the treatment for narrowed or blocked arteries is to use stents (metallic scaffold), which are inserted into a blood vessel in the heart to help open up blockages. A drug-eluting stent (DES) is a device that releases a drug which helps prevent blockages from recurring (a condition called restenosis). However, sometimes despite the use of DESs, restenosis may occur requiring a second procedure. Sometimes treatment may involve the placement of additional stent or the use of a balloon (this is called “plain old balloon angioplasty” or POBA) without placing a new stent. Drug Coated Balloons (DCBs) devices such as the MagicTouchTM Sirolimus-Coated Balloon are like POBA but are coated with a drug which helps to prevent restenosis and may thus be a new option for treating restenosis.