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NCT07815106
OPtimization of Antiplatelet Therapy After the intervenTION of de Novo Coronary Artery Lesions With Drug-Coated Balloons
Conditions: Chronic Coronary Syndrome
Sex: All
Healthy volunteers: No
Phase: PHASE4
Enrollment: 2122
Sponsor: Shanghai Zhongshan Hospital
Summary
Coronary atherosclerotic disease remains one of the leading causes of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) and drug-eluting stents (DES) implantation has significantly improved clinical outcomes, long-term studies have demonstrated that stent-related complications-including late restenosis, very late thrombosis, impaired vascular compliance due to permanent metal residue, and bleeding risk associated with prolonged dual antiplatelet therapy (DAPT)-have yet to be fundamentally resolved. Drug-coated balloon (DCB) has emerged as a "metal-free" alternative strategy, delivering antiproliferative drugs to the vessel wall during balloon expansion, with the aim of reducing metal residue, promoting vascular healing, and lowering the incidence of long-term adverse events.
Multiple high-quality studies have validated the safety and efficacy of DCB in the setting of in-stent restenosis (ISR) and small-vessel de novo lesions. The international DCB consensus has explicitly incorporated ISR and small-vessel disease into the category of established indications. Recent studies have demonstrated that, in small-vessel lesions, DCB is comparable to second-generation DES with respect to target lesion revascularization (TLR) and major adverse cardiovascular events (MACE), while conferring a lower risk of long-term stent-related complications. These advances have prompted relevant expert panels to publish operational standards and indication guidelines for DCB. Meanwhile, the research focus of DCB is gradually expanding toward "large-vessel de novo lesions." This lesion subset is typically characterized by a reference vessel diameter ≥2.75-3.0 mm, high lesion burden, and impaired vascular compliance. Several international studies have found that, under conditions of adequate lesion preparation-defined as residual stenosis \
Eligibility Criteria
Inclusion Criteria:
1. Diagnosed with chronic coronary syndrome (CCS);
2. Underwent DCB treatment, with no ischemic or bleeding events within 1 month after the procedure;
3. Received dual antiplatelet therapy consisting of aspirin plus a P2Y₁₂ receptor inhibitor;
4. Agreed to participate in the study.
Exclusion Criteria:
1. Left-main lesion; or lesion location/characteristics (e.g., heavy tortuosity, severe focal calcification, complex bifurcation lesions, slow-flow phenomenon) precluding a DCB-only strategy;
2. Severe calcified lesions with residual calcium-plate support \>50% after lesion pre-treatment;
3. Stroke occurring within the recent 3 months, or patients requiring routine anticoagulation therapy;
4. Severe hepatic or renal insufficiency (eGFR \< 30 mL/min), bleeding diathesis, or recent major bleeding;
5. Infertile or pregnant female patients; any factors that may interfere with follow-up or participation in other studies;
6. Patients unable to comply with study requirements, with estimated survival \< 1 year, or those with psychological or other factors hindering complete follow-up;
7. Patients deemed ineligible for participation in this study by the investigators.
Source: ClinicalTrials.gov (NCT07815106). StuddyBuddy aggregates publicly available trial information.