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

NCT05101005 | Unknown

• 1 other identifier: SJDCB-01
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Coronary Artery Disease; Drug-coated Balloon

Outcome Measures

Primary Outcomes (1)

• Target lesion failure

  A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization

  12 months follow-up

Secondary Outcomes (3)

• Procedural success

  During the hospital stay, up to 7 days after PCI

• Target lesion failure

  1 month, 6months follow-up

• Patient-oriented composite endpoint

  1 month, 6months,12 months follow-up

Study Arms (2)

Drug-coated balloon

EXPERIMENTAL

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

Device: Drug-Coated Balloon

Sirolimus-Eluting Stent

ACTIVE COMPARATOR

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

Device: Sirolimus-Eluting Stent

Interventions

Drug-Coated Balloon DEVICE

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

Drug-coated balloon

Sirolimus-Eluting Stent DEVICE

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

Sirolimus-Eluting Stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤80 years, regardless of gender;
• De novo lesion in a native coronary artery;
• Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
• Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
• The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
• 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.

You may not qualify if:

• Reference vessel diameter \<2.75 mm or \>4.0 mm;
• In stent restenosis;
• Left main lesion, chronic complete occlusion lesion;
• Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
• There is a large scale of thrombus in the target vessel, and the thrombus grade \>3 after thrombolysis or aspiration;
• Severe heart failure (NYHA IV);
• Severe renal failure (GFR\<30ml/min) or undergoing hemodialysis treatment;
• 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);
• Patients with vein graft restenosis after bypass or severe heart valve disease;
• Pregnant or breastfeeding female patients;
• The life expectancy of the patient is less than 12 months;
• 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;
• Anemia (women's hemoglobin \<117g/L, or men's hemoglobin \<134g/L), or thrombocytopenia detected before the intervention within 6 months (\<100×10⁹/L);
• Planned to perform non-cardiac surgery within 12 months after index procedure;
• The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint;

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yansong Li

  Shanghai Songjiang Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yansong Li

CONTACT

8618221277176; liyansong021@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 29, 2021
• Study Start: October 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share