Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis

Exclusion Criteria

• •General criteria
• •1. Patients with myocardial infarction within 1 week before index procedure.
• •2. Patients with takayasu arteritis.
• •3. Patients with severe renal failure, whose Creatinine \>2.0 mg/dL (177 mol/L).
• •4. LVEF\<30%.
• •5. Hb before procedure \<10 g/dL.
• •6. Patients with Coagulation disorder, platelet count \<100,000/mm3.
• •7. Patients with cardiogenic shock.
• •8. Patients with diseases who require cytostatic or radiotherapy.
• •9. Patients who are known to be allergic or contraindicated to aspirin, heparin, clopidogrel, rapamycin, ticagrelor, tirofiban, paclitaxel, or iopromide , or who are allergic to contrast agents and cannot be medically prevented, or who are on cilostazol anticoagulants.
• •10. Patients with bleeding conditions, or with conditions that increase the risk of bleeding, such as gastrointestinal ulcers, which may be restricted or prohibited from anticoagulant therapy or the use of anticoagulant drugs.
• •11. Gestational women who were pregnant before receiving treatment with the study device or who planned to be pregnant during the study , and did not use effective contraception until (including) follow-up at 12 months postoperatively; Female patients during lactation.
• •12. Patients with a life expectancy less than 1 year.
• •13. Patients who are participating in any other clinical trial.
• •14. Investigator considered the patients ineligible due to any reasons.
• •lesion related
• •1. There are more than 3 lesions to be treated (including non-target lesions to be treated), and there are more than 2 lesions to be treated in each coronary artery.
• •2. There will be more than 5 stents implanted in coronary artery after intervention (including previous and current PCI).
• •3. After pre-dilatation of target lesion, there will be residual stenosis of target lesion \>30% or TIMI blood flow \< grade 3, and/ dissections NHLBI grade C,D,E,F.
• •4. The ISR lesion has been treated in past 6 months.
• •5. The target lesion is tortuous, severely calcified, angular, and the DCB is expected to be impassable.
• •6. Target lesion contains thrombosis.
• •7. Target or non-target lesion(s) located in left main.
• •8. Patients with previous CABG.
• •9. Patients with lesions requiring intervention treatment in 3 vessels