A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population
A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population
The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.
Inclusion Criteria:
Related to the patients:
Age ≥18 years old
Patients who agree to accept the angiography follow-up visit at 9-month and follow up visits at 1-month, 6-month, 9-month, 1-year, 2-year, 3-year, 4-year and 5-year
Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia
Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
Related to lesion:
Restenosis after the first stent implant (including bare metal stents, stents with inert coating, and stents with active coating): Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤ 26mm
Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
The distance between other lesion requires interventional therapy and the target lesion must be > 10mm
One subject is allowed to have 2 target lesions at most, and 1 paclitaxel drug balloon for each lesion for dilation
Residual stenosis must be ≤ 30% after pre-dilatation, and dissection must be ≤ NHLBI type B
Exclusion Criteria:
Related to patients
Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
Patients with cardiogenic shock
The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency according to the investigator. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate aspirin or clopidogrel. Patients who are not able to tolerate and comply with dual antiplatelet therapy for at least 3 months after operation
Patients who have Myocardial Infarction with thrombus or coronary slow flow symptoms and require immediate intervention
Patients who had ST-Elevation Myocardial Infarction within 1 week before being included
Patients with severe congestive heart failure or NYHA grade IV heart failure
Patients with moderate or severe valvular heart disease
Patients who had heart transplantation
Patients with renal insufficiency (eGFR < 30mL/min)
The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
The patients are participating in any other clinical trials before reaching the primary endpoints
Patients who are unsuitable for the study according to the investigator due to other reasons
Related to the Lesion:
Patients with total occlusion at the target lesion
Lesion which cannot be treated by percutaneous transluminal coronary angioplasty (PTCA) or percutaneous intervention (PCI)
Reference vessel diameter < 2.0mm
Patients with multiple lesions (≥ 3) requiring percutaneous coronary intervention treatment in the same artery
3-vessel disease that all need to be intervened
The diameter of the branch lesions in the target lesion ≥ 2.5mm
LM lesions and Ostial lesion within 5mm to the root aorta
Non-target lesion was not intervened successfully before target lesions being intervened
Related to concomitant therapy:
Patients cannot tolerate aspirin and/or clopidogrel and or tricagrelor, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel
Patients known allergic to paclitaxel
Patients known allergic to contrast materials