Coronary In-stent Restenosis
Conditions
Interventions
Study group:Paclitaxel Drug-eluting Coronary Artery Balloon Catheter (SeQuent Please)
Control group:Paclitaxel Drug-eluting Coronary Stent and Conveying System (Taxus Liberte)
Sponsors
Fuwai CVD Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Related to patients: 1. Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia; 2. Restenosis after the first stent implant; 3.Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting); 4. Patient aged 18-80 (including 18 and 80); 5. Female patients of childbearing age in the study period shall not be pregnant or protocol to be pregnant, it is suggested that patients shall take sufficient contraception measures till (including) the follow-up visit of month 9; 6. Patients who agree to accept the angiography follow-up visits of month 9; 7. Patients who agree to accept the clinical visits at Day 30, Month 6 and Month 12; 8. Patients can understand the study objectives psychologically and linguistically and show the sufficient compliance to the study protocol. Patients present acceptance of the risks and benefits described in the informed consent form. Related to lesion 1. Stent (including naked stent, inertial coating and active drug coating) restenosis: Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length =70% or >=50% and accompanied by ischemia; 3. The distance between other lesion requires interventional therapy and the target lesion must be >10mm; 4. In the stent group, up to two paclitaxel drug stents are permitted to be implanted in series.
Exclusion criteria
Exclusion criteria: Related to patients 1. Patients with myocardial infarction within one week; 2. Patients with severe congestive heart failure or NYHA IV severe heart failure; 3. Patients with severe valvular heart disease; 4. Female patients in pregnancy or lactation; 5. Patients with the life expectancy not exceeding 1 year or the factors causing difficult clinical follow-up visits; 6. Patients with hemorrhagic tendency, prohibited to take anticoagulants or antiplatelet drugs; 7. Patients with stroke within 6 months before the surgery; 8. Patients taking part in any other clinical tests; 9. Existing sever renal failure (GFR=2.5mm; 5. Percutaneous coronary intervention of venous graft; 6. Entire shut of Grade TIMI 0 blood flow (Type Mehran IV stenosis); 7. Open lesion at left primary and within 2mm; Related to concomitant therapy 1. Patients cannot tolerate aspirin and/or clopidogrel, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel; 2. Patients known allergic to paclitaxel; 3. Patients with the history of leucopenia (numeration of leukocytes <3*10^9/L, exceeding 3 days), neutrocytopenia (ANC<1000 neutrocytes/mm3, exceeding 3 days) or thrombocytopenia (<100,000 platelets/mm3; 4. Patients with the history of peptic ulcer or gastrointestinal hemorrhage in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss in lesion section at Month 9; | — |
Countries
China
Contacts
Public ContactGao Runlin
Outcome results
None listed