Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease

Inclusion criteria

Related to the patients:

• Age ≥18 years old
• Patients with stable or unstable angina pectoris, or recent myocardial infarction which has been stabilized (occurred over 7 days before enrollment, including non-st segment elevation myocardial infarction(NSTMI) and STMI), or proved asymptomatic regional myocardial ischemia
• Patients in the small vessel cohort should be suitable for balloon dilation angioplasty or stent implantation, patients in the very small vessel cohort should be suitable for balloon dilation angioplasty.
• Patients should have sufficient compliance and agree to receive follow-ups in month-1, 6, 9 and 12, and follow-up visit in year-2, 3, 4, and 5. It is required to perform angiography in month-9.
• Patients should volunteer to participate in this study, and sign the written informed consent form, and understand all risks and benefits in the informed consent document.

Related to the diseases:

• Patients with de novo, in situ lesions of small coronary vessels, the length of the lesion should be ≤26mm according to visual inspection. In the small vessel cohort, the diameter of the target lesion should be ≥2.25mm and ≤2.75mm according to visual inspection, and in the very small vessel cohort, the diameter of the target lesion should be ≥2. 00mm and <2.25mm according to visual inspection.
• The diameter stenosis according to visual inspection before intervention treatment should be ≥70% or ≥50% with the evidence of ischemia.
• Each patient is allowed to have only one lesion of the target small vessel (2 lesions with the distance ≤10mm and total length ≤26mm which could be treated with the same balloon or stent is considered as one lesion).

Exclusion criteria

Related to the patients:

• Myocardial infarction occurred within 1 week before enrollment.
• Patients with severe congestive heart failure or New York Heart Association (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 in the past 6 months, or the patients have a bleeding tendency according to the investigator.
• Patients with a history of leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000/mm3 for more than 3 days) or thrombocytopenia (platelet <100,000/mm3)
• 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 known to be allergic to Paclitaxel or Zotarolimus
• The patients have a life expectancy of less than 1 year, or it would be difficult to finish follow-ups within 1 year.
• Pregnant or lactating women, or female patients at a child-bearing age who plan to get pregnant during the period of the study or could not take effective contraceptives
• The patients are participating in any clinical trials of other drugs or devices before reaching the primary endpoints.
• Patients who are unsuitable for the study according to the investigator due to other reasons

Related to the diseases:

• Patients with total occlusion of the target vessel
• The patients have severe calcification of the target lesion, and therefore balloon pre-dilation 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) requiring intervention treatment
• There are more than 2 non-target lesions which require treatment, or could not be treated with intervention before the target lesion, or the treatment had failed.