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

Trial details

Who runs it

Sir Run Run Shaw Hospital

Trial code

NCT07920055

Record updated

5 November 2026

Original description

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.Read full original descriptionShow less

Sirolimus-Coated Balloon (SeQuent SCB) Versus Paclitaxel-Coated Balloon (RESTORE DEB) for Recurrent Coronary In-Stent Restenosis Following Prior Paclitaxel-Coated Balloon Therapy: A Multicenter, Randomized, Open-Label, Noninferiority Trial

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: Age ≥18 years; 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; 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; Quantitative coronary angiography shows diameter stenosis ≥70%, or ≥50% with evidence of myocardial ischemia; Suitable for either type of coronary revascularization under study; Willing to take aspirin and clopidogrel for 3 months, followed by aspirin monotherapy through study completion; Willing to undergo angiographic and IVUS follow-up at 9 months and clinical follow-up at 30 days and 6, 9, and 12 months; Able to understand the study, provide written informed consent, and comply with study procedures; 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; 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: Concomitant disease requiring cytotoxic treatment or radiotherapy; Prior coronary artery bypass grafting; Known allergy or contraindication to aspirin, heparin, clopidogrel, sirolimus, ticagrelor, tirofiban, paclitaxel, or iopromide; or contrast allergy not manageable with prophylaxis; Bleeding diathesis or a condition such as gastrointestinal ulcer that limits or prevents required antithrombotic therapy; Critical illness or life expectancy ≤1 year; Three-vessel disease requiring treatment (all three major epicardial vessels with ≥70% stenosis and ischemia) or left main coronary disease; eGFR <30 mL/min/1.73 m² or dialysis; ALT or AST >3 times the upper limit of normal; Left ventricular ejection fraction <30%; Active bleeding, major bleeding within 3 months, or preprocedural hemoglobin <10 g/dL; Platelets <100,000/mm³ or INR >1.5 in the absence of anticoagulation; Takayasu arteritis or active vasculitis; Cardiogenic shock; Pregnancy, planned pregnancy during the study, inability to use effective contraception through the 12-month visit, or breastfeeding; Participation in another interventional study; Investigator judgment that the participant is unsuitable for the study; More than three lesions expected to require treatment overall, or more than two lesions requiring treatment in any coronary artery; Target lesion with residual stenosis >30%, TIMI flow <3, or type C or worse dissection after predilatation; Target lesion with tortuosity, severe calcification, or angulation expected to prevent passage of the study balloon; Thrombus-containing target lesion.

ClinicalTrials.gov NCT07920055