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
Not Applicable
- Conditions
- Diffuse Coronary Artery Lesions
- Interventions
- Device: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)Device: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)
- Registration Number
- NCT03589157
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description second-generation drug-eluting stent group drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES) - Drug-coated balloon group drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) -
- Primary Outcome Measures
Name Time Method Late lumen loss 9 months Late lumen loss (LLL) in the lesion segment within 9 months after surgery
- Secondary Outcome Measures
Name Time Method Interventional therapy success rate 3 years including device success rate, lesion success rate and clinical success rate
Clinically-driven target lesion revascularization 3 years Clinically-driven target lesion revascularization (CD-TLR) at 30 days and 3, 6, 9, 12, 24 and 36 months postoperatively
Device-related cardiovascular clinical composite endpoints 3 years including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short
Patient-related cardiovascular clinical composite endpoints 3 years including all-cause mortality, all myocardial infarctions, and any revascularization
Restenosis rate (RR) in the lesion segment 9 months Restenosis rate (RR) in the lesion segment on 9 months after operation