Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis

You may not qualify if:

• Patients oriented
• Subjects with consistent clinical symptoms and/or ECG changes and/or cardiac enzymes changes with MI (including STEMI and Non-STEMI) within one week;
• Subjects with cardiac shock, hemodynamic instability or refractory ventricular arrhythmia that require positive inotropic drugs or mechanical circulation support;
• Subjects with one of following conditions (from screening period to the day of operation): (1) life expectancy is less than 1 year because of other severe diseases (like cancer), (2) drug abuse at present (like alcohol, cocaine, heroin and so on), (3) plan to accept surgery that may cause the programs not to be complied with or confusing with data understanding;
• Subjects with bleeding diathesis or active gastrointestinal ulcers, or stroke/transient ischemic attack within 3 months;
• Subjects with severe congestive heart failure or severe heart failure at the level of NYHA IV;
• Subjects are receiving dialysis or baseline serum creatinine levels\>2.0 mg/dL(177μmol/L);
• Subjects with severe valvular heart disease;
• Subjects who have been or are scheduled for a heart transplantation during the trial;
• Subjects who have been pregnant or is planning to be pregnant or is breastfeeding during the trial;
• Subjects who are participating in any other clinical trial;
• Researchers don't think they're suitable for the trial because of other reasons;
• Lesions oriented (Visual estimation)
• Total occlusion with TIMI 0 (Mehran IV stenosis);
• With the evidence of widespread thrombi in the target vessels prior to intervention;
• +9 more criteria