This study is looking at a treatment for in-stent restenosis (ISR), which is when a coronary artery (heart artery) narrows again after a stent has been placed. Researchers are comparing a special balloon called MagicTouch™ Sirolimus-Coated Balloon to a standard balloon angioplasty (POBA) to open these narrowed arteries. You might be able to join if you are at least 18 years old and have ISR. The main goal is to see if the MagicTouch™ balloon is safe and effective in preventing the artery from narrowing again, measured at 12 months. The study plans to enroll about 492 participants across the United States, but its current recruitment status is unclear.

Study design

This is a randomized study where participants will be assigned to one of two treatment groups. Approximately 492 people will be enrolled.

What's involved

You will have a medical history review, physical exam, lab tests, and an ECG before the procedure. Women of childbearing potential will also have a pregnancy test. After treatment, you will have clinical assessments, ECGs, and blood draws during your hospital stay.

Compensation

Not stated in the trial record.

Follow-up

The main outcome of the study, Target Lesion Failure (TLF), will be measured at 12 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.