Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)

This prospective, multicenter, randomized, open-label, noninferiority trial will compare a sirolimus-coated balloon (SeQuent SCB) with a paclitaxel-coated balloon (RESTORE DEB) in 106 adults with recurrent coronary in-stent restenosis after prior paclitaxel-coated balloon treatment of the same segment. Participants will be randomized 1:1 to treatment of the target lesion with one of the study devices. The primary outcome is in-segment late lumen loss on quantitative coronary angiography 9 months after the index procedure. Clinical follow-up is scheduled at 30 days and 6, 9, and 12 months. Angiographic analysis and clinical event adjudication will be performed blinded to treatment assignment.

Inclusion Criteria: 1. Age ≥18 years. 2. Stable angina, acute coronary syndrome (NSTEMI at least 7 days after onset or STEMI at least 30 days after onset), prior myocardial infarction, or documented asymptomatic myocardial ischemia. 3. Prior treatment of coronary in-stent restenosis with a paclitaxel-coated balloon alone; recurrent restenosis is in the previously treated segment, including 5 mm beyond the stent edge. 4. Quantitative coronary angiography shows diameter stenosis ≥70%, or ≥50% with evidence of myocardial ischemia. 5. Suitable for either type of coronary revascularization under study. 6. Willing to take aspirin and clopidogrel for 3 months, followed by aspirin monotherapy through study completion. 7. Willing to undergo angiographic and IVUS follow-up at 9 months and clinical follow-up at 30 days and 6, 9, and 12 months. 8. Able to understand the study, provide written informed consent, and comply with study procedures. 9. At least one recurrent target in-stent restenosis lesion requiring intervention, in one target vessel, with no more than two target lesions; any other de novo lesion requiring intervention must be \>10 mm away from a target lesion. 10. Mehran type I, II, or III in-stent restenosis of a bare-metal, inert-coated, or drug-eluting stent; target reference vessel diameter 2.5-4.0 mm and each target-lesion length ≤34 mm. Exclusion Criteria: 1. Takayasu arteritis or active vasculitis. 2. eGFR \3 times the upper limit of normal. 4. Left ventricular ejection fraction \