Stable Angina Pectoris Clinical Trial
Official title:
Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Long De Novo Lesions of Main Coronary Arteries
This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | February 1, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. a diagnosis of stable angina or unstable angina in hospitalized patients. Objective clinical evidence of ischemia (ECT, Exercise ECG, ECG ST-T changes) With CAG proven one vessel lesion(a lesion length of = 20mm); 2. a lesion diameter stenosis >75% as evaluated by QCA with a reference diameter of = 2.75 mm and = 3.5 mm . 3. a willingness or ability to provide informed consent,a willingness to receive telephone followed-up at postoperative 1 month, 3 month, 6 month, and an angiographic follow up at postoperative 9 month. 4. a willingness to receive DCB angioplast or DES implantation. Exclusion Criteria: 1. Patients with acute myocardial infarction within 30 days; 2. a previous history of severe valvular heart disease,severe hepatic and renal insufficiency;severe cardiac dysfunction with EF=40%; 3. advanced cancer with a life expectancy of <12 months; 4. Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy; 5. Pregnant and lactating patients; 6. Multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions; 7. Stent restenosis 8. Thrombotic disease,severe calcified lesions(Judged by the operator, CAG showed class 2 or more severe calcified lesions),spontaneous dissection or ulcerative lesion,coronary ostial lesions (the lesion included should be an interval of greater than 3mm from the ostial of RCA or LAD), severe angulated lesions(>45°) 9. diameter of collateral vessel= 2.25 mm requiring interventional therapy,type 1 coronary lesions(Patients with diameter of collateral vessel< 2.25 mm, who were not treated with DCB dilatation were also eligible). |
Country | Name | City | State |
---|---|---|---|
China | The People's Hospital of Liaoning Province | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
The People's Hospital of Liaoning Province |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QCA late lumen loss | minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography) | Immediately after the procedure and at 9 months follow-up |
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