A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease

Inclusion criteria

Related to the patients:

Cohort A:

• 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 (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
• Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)

Cohort B: All candidates for Cohort B of this study must meet number 1, 2 of the above criteria and

• Patients who can receive balloon angioplasty

Related to lesion:

Cohort A

• The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
• Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
• One subject is allowed to have 1 target lesion at most (Two lesions can be treat as one target lesion, if they are in the same vessel, with the distance less than 10mm, with total length ≤ 26mm, and can be intervened by one DCB or DES)

Cohort B: All candidates for Cohort B of this study must meet number 6,7 of the above criteria and

• The reference blood vessel diameter is 2.00mm-2.25mm

Exclusion criteria

Related to patients

• Patients who had Myocardial Infarction within 1 week before being included
• Patients with severe congestive heart failure or NYHA grade IV heart failure
• Left ventricular ejection fraction (LVEF) < 35%
• Patients who had heart transplantation
• Patients with severe valvular heart disease
• 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 with leukopenia (white blood cell count < 3×10^9/L) for more than three days; Patients with low neutrophil counts (ANC < 1000/mm^3) for more than three days; Patients with thrombocytopenia (platelet count < 100,000/mm^3)
• Patients with renal insufficiency (eGFR < 30mL/min)
• Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
• Patients who are allergic to Paclitaxel or Zotarolimus
• The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months
• Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
• 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
• Patients who have severe calcification of the target lesion, and balloon pre-dilatation could not be performed successfully
• The target lesions are bifurcation lesion with the diameter of the branch vessel > 2.00mm
• The target lesions are in-stent restenosis
• Angiography indicates thrombosis in the target vessel
• Complicated with lesions in left main (LM) coronary requiring intervention treatment
• More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion