The Efficacy and Safety of SeQuent® Please in the Treatment of Small Vessel Disease (SVD) Patient

Inclusion Criteria: Criteria related to subjects

• Patients with stable angina pectoris, or unstable angina pectoris, or old myocardialinfarction, or documented silent ischemia;

• At the age of 18-80;

• Women of childbearing potential may not be pregnant nor have the desire to becomingpregnant during the study. Hence, patients will be advised to use an adequate birthcontrol method up to (including) the end of follow-up;

• Patients must agree to undergo the 9-month angiographic follow-up and the clinicalfollow-up at 30 days, 6 months, 9 months and 12 months after operation;

• Patients who are psychologically and linguistically able to understand the purpose ofthe study, and show sufficient compliance with the study protocol;

• Patients who have expressed acknowledgment of the risks and benefits described in theinformed consent document by providing informed consent; Criteria related to lesions

• The target lesion is primary, in situ coronary artery lesion located in 1 or 2different coronary arteries, with no more than 1 target lesion in each coronaryartery;

• The reference vessel diameter is within the range of 2.0 mm - 2.75 mm; (visuallymeasured)

• Interventional treatment should be conducted on lesion(s) of non-target vessel(s) inadvance (which must be concurrent treatment), and management of random and targetlesions should be performed after successful treatment of non-target lesion(s);

• The pre-operative diameter stenosis must be either ≥ 70% or ≥ 50% with ischemia; (visually measured)

• Each target lesion should be treated with only one SeQuent® Please or SeQuent® Neo.

Exclusion Criteria: Criteria related to subjects

• Patients with recent myocardial infarction (within one week), or patients withmyocardial infarction over one week but whose troponin level has not recovered tonormal;

• Patients with severe congestive heart failure or NYHA class IV heart failure;

• Patients with severe valvular heart disease;

• Women who are pregnant or lactating;

• Patients with remaining life expectancy of no more than 1 year or with factors causingdifficulty in clinical follow-up;

• Patients who had cerebral stroke within 6 months before operation;

• Patients who are currently involved in any other clinical trial;

• Patients with presence or history of severe hepatic failure and therefore are noteligible for angiography;

• Patients with presence or history of severe renal failure (GFR < 30 ml/min) andtherefore are not eligible for angiography;

• Patients who have received heart transplant;

• Patients with cardiogenic shock;

• Patients with left ventricular ejection fraction less than 30%;

• Patients suffering from coronary artery spasm without significant stenosis;

• Patients considered as ineligible by the investigator for other reasons; Criteria related to lesions

• Evidence of extensive thrombosis in target vessel before intervention;

• Percutaneous coronary intervention of venous graft;

• Chronic total occlusion (TIMI 0 flow before operation);

• Left main disease and/or triple vessel disease needed to be treated, bifurcationlesion with branch vessel diameter ≥ 2.5 mm, and bypass graft lesion;

• There is non-target lesion(s) in the proximal large vessel and target lesion(s) in thedistal small vessel of the same vessel (eligible if there is non-target lesion(s) inproximal large vessel and a target lesion in the bifurcated small vessel);

• The target vessel is distorted or has calcified lesion(s);

• Lesion within 5 mm away from the coronary artery ostium;

• Lesion that cannot be treated with PTCA or other interventional techniques;

• After pre-dilation of target lesion, the residual stenosis is ≥ 30% or TIMI flow is < 3, and/or type C or above dissection appears; Exclusion criteria related to concomitant medication

• Patients prone to bleeding and contraindicated for anticoagulant or antiplateletdrugs;

• Patients who are intolerant to aspirin and/or clopidogrel or have a history ofneutrophilopenia or thrombocytopenia, or patients with severe hepatic insufficiencyand contraindicated for clopidogrel.

• Patients who are known to be intolerant or allergic to heparin, contrast agent,paclitaxel, iopromide, rapamycin, polylactic acid - glycolic acid polymer, stainlesssteel;

• Patients with a history of leukopenia (leukocyte count < 3 × 109/L for more than 3days), neutrophilopenia (ANC < 1,000 neutrophils/mm3 for more than 3 days), orthrombocytopenia (< 100,000 platelets/mm3);

• Patients with a history of peptic ulcer or gastrointestinal bleeding in the past 6months