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

Coronary Artery Disease Clinical Trial

Official title:

A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05101005
• Other study ID #: SJDCB-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: November 2023

Study information

• Verified date: October 2021
• Source: Lepu Medical Technology (Beijing) Co., Ltd.
• Contact: Yansong Li
• Phone: 8618221277176
• Email: liyansong021[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 (<100×10?/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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Drug-coated Balloon

Intervention

Device:
• Drug-Coated Balloon
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lepu Medical Technology (Beijing) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization	12 months follow-up
Secondary	Procedural success	Consisting of device success ( after successful delivery of the study balloon, the visual residual stenosis of the target lesion is less than 50%, TIMI level 3 blood flow ) , Lesion success (defined as the proportion of the target lesions in which the final stenosis is <20% after treatment with any other adjunctive therapy ) , Clinical success ( Defined as no major adverse cardiac events caused by ischemia during the subject's hospitalization).	During the hospital stay, up to 7 days after PCI
Secondary	Target lesion failure	A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization	1 month, 6months follow-up
Secondary	Patient-oriented composite endpoint	A composite of all-cause mortality, myocardial infarction, and any revascularization	1 month, 6months,12 months follow-up