A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis

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