Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

Lepu Medical Technology

Status: Unknown

Conditions: Coronary Artery Disease; Drug-coated Balloon

Treatments: Device: Sirolimus-Eluting Stent; Device: Drug-Coated Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT05101005

SJDCB-01

Details and patient eligibility

About

To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).

Full description

Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years and ≤80 years, regardless of gender;
2. De novo lesion in a native coronary artery;
3. Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
4. Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
5. The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
6. The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up.

Exclusion criteria

1. Reference vessel diameter <2.75 mm or >4.0 mm;
2. In stent restenosis;
3. Left main lesion, chronic complete occlusion lesion;
4. Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
5. There is a large scale of thrombus in the target vessel, and the thrombus grade >3 after thrombolysis or aspiration;
6. Severe heart failure (NYHA IV);
7. Severe renal failure (GFR<30ml/min) or undergoing hemodialysis treatment;
8. Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal);
9. Patients with vein graft restenosis after bypass or severe heart valve disease;
10. Pregnant or breastfeeding female patients;
11. The life expectancy of the patient is less than 12 months;
12. The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications;
13. Anemia (women's hemoglobin <117g/L, or men's hemoglobin <134g/L), or thrombocytopenia detected before the intervention within 6 months (<100×10⁹/L);
14. Planned to perform non-cardiac surgery within 12 months after index procedure;
15. The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint;
16. Heart transplant patients;
17. Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel;
18. The investigator judged that the patient had poor compliance and could not complete the study as required.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Drug-coated balloon

Experimental group

Description:

Drug-coated balloon is used to treat coronary artery stenosis lesions and improve myocardial blood flow.

Treatment:

Device: Drug-Coated Balloon

Sirolimus-Eluting Stent

Active Comparator group

Description:

Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.

Treatment:

Device: Sirolimus-Eluting Stent