Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial

Study Overview
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Brief Summary
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The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.

Official Title
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Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial

Conditions
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Diffuse Coronary Artery Lesions

Intervention / Treatment
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* Device: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)
* Device: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient-related Patients who have typical angina pectoris symptoms with obvious evidence of ischemia; Patients whose ages are between 18-80 years; Patients who must agree to receive a 9-month angiographic follow-up; Patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months; Patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol; Patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent; Lesion-related Diffuse coronary artery disease in situ; Reference target vessel diameter of 2.5-4.0 mm and length of > 25 mm; Non-target vessel lesions needing to receive a successful intervention therapy first before randomization to receive treatment for target lesions (note: within the same hospitalization); Visually estimated diameter stenosis of ≥70%, or diameter stenosis of ≥50% with objective evidences of ischemia (treadmill exercise testing, ECT or FFR<0.8) Exclusion Criteria: Patient-related: Patients who have the attack of myocardial infarction within the past week, or whose troponin fails to return to normal although myocardial infarction has occurred for over one week; Patients with serious congestive heart failure or NYHA IV-level serious heart failure; Patients whose left ventricular ejection fraction is < 30%; Patients who have medical history of stroke or TIA within 6 months prior to the surgery; Patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography; Patients who have a current or previous history of serious kidney failure (GFR<30 ml/min) and thereby fail to meet the requirements of angiography; Patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage; Patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically; Patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of ADP receptor antagonists; Pregnant or lactating women or women who are planning to become pregnant during the study. Patients participating in any other clinical trial; Patients who are considered not suitable for inclusion by the investigator for any other reason; Lesion-related: Patients who have the evidence of extensive thrombosis in target vessels prior to the interventional therapy; Patients who have left main coronary artery disease or graft lesions needing to be treated; Patients who have bifurcation lesions with a side-branch vessel diameter of >2.5 mm; Patients who have lesions at the ostia of coronary artery, at the circumflex branch, at the ostia of anterior descending branch or within 5 mm at the ostia of coronary artery; Severe intimal tear disease; In-stent restenosis; Lesions which can not be treated with PTCA or other intervention technologies; Lesions with serious calcification; Concomitant medication related Patients who have a physique prone to hemorrhage and are prohibited from taking anticoagulants or antiplatelet drugs; Patients who can not tolerate Aspirin and/or Clopidogrel, or who have serious hypohepatia and must not use Clopidogrel; Patients who can not tolerate or have known allergy to heparin, contrast media, paclitaxel, iopromide, rapamycin, poly(lactic-co-glycolic acid) polymers or stainless steel, etc,; Patients with a history of leukopenia (with WBC<3×109/L for more than 3 days), neutropenia (with ANC <1,000 cells/mm3 for more than 3 days), or thrombocytopenia (with platelet count <100,000/mm3);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-coated balloon group<br> | Device: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)<br>* using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions<br>|
| Active Comparator: second-generation drug-eluting stent group<br> | Device: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)<br>* using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss | Late lumen loss (LLL) in the lesion segment within 9 months after surgery | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interventional therapy success rate | including device success rate, lesion success rate and clinical success rate | 3 years | 
| Restenosis rate (RR) in the lesion segment | Restenosis rate (RR) in the lesion segment on 9 months after operation | 9 months | 
| Clinically-driven target lesion revascularization | Clinically-driven target lesion revascularization (CD-TLR) at 30 days and 3, 6, 9, 12, 24 and 36 months postoperatively | 3 years | 
| Device-related cardiovascular clinical composite endpoints | including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short | 3 years | 
| Patient-related cardiovascular clinical composite endpoints | including all-cause mortality, all myocardial infarctions, and any revascularization | 3 years |