CHINA RESOLUTE INTEGRITY STUDY Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use --A Prospective, Multi-center, Single Arm, Non-randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Device Specific Procedural Success
研究概览
简要总结
The purpose of this study is to conduct a prospective, multi-center, single arm, non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
详细描述
This is a Pre-market, Prospective, Multi-center, Single arm, Non-randomized Study.
The objective of this study is to:
- To assess the deliverability of the Resolute Integrity Stent for suitable patients according to Indication for Use with a reference vessel diameter (RVD) of 2.25 mm to 4.0 mm in 200 evaluable patients
- To assess the in-hospital Major Adverse Cardiac Event (MACE) rate
- To collect data on resource utilization in the catheterization lab. At least 200 evaluable patients from about 15 study centers in China who meet the eligibility criteria and sign the informed consent form will participate in this study.
The expected time of participation in the study for each subject is from informed consent sign-off up to hospital discharge.
An angiographic core laboratory and a Clinical Events Committee (CEC) will be utilized. Adjudication of pre-specified clinical endpoint events will be done by an independent Clinical Events Committee. An angiographic core laboratory will review all baseline, procedural, and clinical event angiograms for all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is older than or equal to 18 years
- •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 Integrity stent
- •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 implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI)
- •Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations
排除标准
- •Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- •History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- •A woman who is pregnant, planning to be pregnant or lactating
- •Currently participating in another trial
- •Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period
- •Previous enrollment in the China Resolute Integrity Study
研究组 & 干预措施
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
This is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study.
干预措施: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (Device)
结局指标
主要结局
Device Specific Procedural Success
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Defined as device success (the attainment of less than 50% residual stenosis of the target lesion using only the study device) and no in-hospital MACE (composite of death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization).
次要结局
- Delivery Success(Participants will be followed at the end of index procedure, an expected average of 3 days.)
- Device Success(Participants will be followed at the end of index procedure, an expected average of 3 days.)
- Lesion Success(Participants will be followed at the end of index procedure, an expected average of 3 days.)
- Procedure Success(Participants will be followed for the duration of hospital stay, an expected average of 5 days.)
- In-hospital Major Adverse Cardiac Events (MACE)(Participants will be followed for the duration of hospital stay, an expected average of 5 days.)
- In-hospital Target Lesion Failure (TLF)(Participants will be followed for the duration of hospital stay, an expected average of 5 days.)
- Contrast volume used (ml)(Participants will be followed at the end of index procedure, an expected average of 3 days.)
- Usage of guiding catheters(Participants will be followed at the end of index procedure, an expected average of 3 days.)
- Usage of guide wires(Participants will be followed at the end of index procedure, an expected average of 3 days.)
- Usage of angioplasty balloons(Participants will be followed at the end of index procedure, an expected average of 3 days.)
- Procedure time (min)(Participants will be followed at the end of index procedure, an expected average of 3 days.)