RESOLUTE China RCT (R-China RCT)
Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring In-stent Late Lumen Loss (LLL), TARGET VESSEL FAILURE (TVF), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI), REAL-WORLD, THE RANDOMIZED CONTROLLED TRIAL
Eligibility Criteria
Inclusion Criteria:
Patient must meet all of the following criteria to be eligible for treatment in the trial:
- Age ≥ 18 years or minimum age as required by local regulations
- The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and Taxus Liberte stent and the Declaration of Helsinki
- The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
- Intention to electively implant at least one Resolute stent or Taxus Liberte stent
- The patient is willing and able to cooperate with study procedures and required follow up visits
Exclusion Criteria:
Patients will be excluded from the trial if any of the following criteria are met:
- Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, 316L stainless steel, polymer coatings (e.g. Biolinx), zotarolimus, paclitaxel, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
- Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
- Previous enrollment in the Resolute China RCT
Sites / Locations
- An Zhen Hospital
- Beijing Fu Wai Hospital
- The First Affiliated Hospital, Sun Yat-sen University
- First Affiliated Hospital of Medical College of XI'AN Jiaotong University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Medtronic Resolute (Zotarolimus-eluting stent)
Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS).
Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS).