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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05101005
Other study ID # SJDCB-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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