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Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Condition(s) studied
Coronary In-stent RestenosisCoronary Artery Disease
Investigational drug(s) / intervention(s)
SeQuent SCB sirolimus-coated balloonRESTORE DEB paclitaxel-coated balloon
SeQuent SCB sirolimus-coated balloon: Coronary balloon angioplasty of eligible target lesions
RESTORE DEB paclitaxel-coated balloon: Coronary balloon angioplasty of eligible target lesions
Study summary
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.
Eligibility
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 \<30 mL/min/1.73 m² or dialysis.
3. ALT or AST \>3 times the upper limit of normal.
4. Left ventricular ejection fraction \<30%.
5. Active bleeding, major bleeding within 3 months, or preprocedural hemoglobin \<10 g/dL.
6. Platelets \<100,000/mm³ or INR \>1.5 in the absence of anticoagulation.
7. Cardiogenic shock.
8. Concomitant disease requiring cytotoxic treatment or radiotherapy.
9. Known allergy or contraindication to aspirin, heparin, clopidogrel, sirolimus, ticagrelor, tirofiban, paclitaxel, or iopromide; or contrast allergy not manageable with prophylaxis.
10. Bleeding diathesis or a condition such as gastrointestinal ulcer that limits or prevents required antithrombotic therapy.
11. Pregnancy, planned pregnancy during the study, inability to use effective contraception through the 12-month visit, or breastfeeding.
12. Critical illness or life expectancy ≤1 year.
13. Participation in another interventional study.
14. Investigator judgment that the participant is unsuitable for the study.
15. Three-vessel disease requiring treatment (all three major epicardial vessels with ≥70% stenosis and ischemia) or left main coronary disease.
16. More than three lesions expected to require treatment overall, or more than two lesions requiring treatment in any coronary artery.
17. Target lesion with residual stenosis \>30%, TIMI flow \<3, or type C or worse dissection after predilatation.
18. Target lesion with tortuosity, severe calcification, or angulation expected to prevent passage of the study balloon.
19. Thrombus-containing target lesion.
20. Prior coronary artery bypass grafting.
Primary outcome measure(s)
- In-Segment Late Lumen Loss at 9 Months — Immediately after index procedure and at 9 months
Difference, in millimeters, between the in-segment minimum lumen diameter immediately after balloon angioplasty and the minimum lumen diameter in the same segment at 9 months, measured by blinded quantitative coronary angiography. The prespecified noninferiority margin for the adjusted mean difference (SeQuent SCB minus RESTORE DEB) is 0.25 mm.
Trial sites (1)
| Facility | City | Region | Status |
| Sir Run Run Shaw Hospital |
Hangzhou |
China |
|
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