A Prospective Multicenter Randomized Two-Arm Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch Sirolimus-Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis (MAGICAL ISR)

Brief description of study

The treatment for narrowed or blocked arteries often involves stents, which are inserted into heart blood vessels to alleviate blockages. Drug-eluting stents (DES) release medication to prevent recurring blockages, known as restenosis. However, restenosis can still occur, sometimes necessitating further procedures. These may include placing additional stent layers or using balloon angioplasty (POBA) without new stents, though multiple layers can be a drawback.

This study aims to compare the efficacy and safety of the MagicTouch™ Sirolimus-Coated Balloon combined with POBA versus POBA alone in patients with restenosis of prior DES. All participants will receive standard treatment for narrowed areas in previous DES with POBA. Some patients will also receive the MagicTouch™ balloon. The study will assess the effectiveness of adding this novel device to standard treatment.


Clinical Study Identifier: s23-00924
ClinicalTrials.gov Identifier: NCT05908331
Principal Investigator: Louai Razzouk.
Other Investigators: Atul Sharma, Alexander Slotwiner, Boutros Karam, Anvar Babaev, Sunil Rao, George Fernaine, Rafael Harari, Nathaniel Rosso Smilowitz, Sripal Bangalore, Lindsay Elbaum, Michael J Attubato, Lori Vales Lay, Claudia C Serrano-Gomez, Doris Chan.


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