NCT03589157 - 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 | Crick | Crick
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
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.
using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions
Eligibility
Sex: ALLMin age: 18 YearsMax age: 80 Years
Medical Language ↔ Plain English
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);
Outcomes
Primary Outcomes
Late lumen loss
Late lumen loss (LLL) in the lesion segment within 9 months after surgery
Time frame: 9 months
Secondary Outcomes
Interventional therapy success rate
including device success rate, lesion success rate and clinical success rate
Time frame: 3 years
Restenosis rate (RR) in the lesion segment
Restenosis rate (RR) in the lesion segment on 9 months after operation
Time frame: 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
including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short