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

NCT ID: NCT05101005

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2023-11-30

Brief Summary

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).

Detailed 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.

Conditions

Coronary Artery Disease; Drug-coated Balloon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-coated balloon

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

Group Type: EXPERIMENTAL

Drug-Coated Balloon

Intervention Type: DEVICE

Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.

Sirolimus-Eluting Stent

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

Group Type: ACTIVE_COMPARATOR

Sirolimus-Eluting Stent

Intervention Type: DEVICE

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

Interventions

Drug-Coated Balloon

Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.

Intervention Type: DEVICE

Sirolimus-Eluting Stent

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lepu Medical Technology (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yansong Li

Role: PRINCIPAL_INVESTIGATOR

Shanghai Songjiang Central Hospital

Central Contacts

Yansong Li

Role: CONTACT

Phone: 8618221277176

Email: liyansong021@126.com

Other Identifiers

SJDCB-01

Identifier Type: -

Identifier Source: org_study_id