A Prospective, Multi-center, Single-group Target Value Post-marketing Clinical Study to Evaluate the Safety and Effectiveness of the HT Supreme Drug-eluting Stent System in the Treatment of "Real-world" Patients With Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.
研究概览
简要总结
PIONEER IV CHINA is sought to investigate the safety and efficacy of 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system at 12 months follow-up.
详细描述
This study is a prospective, multi-center, single-arm objective performance criteria clinical trial in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent and treated with 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) in approximately 285 patients (including 80 coronary heart disease cases entering the OCT subgroup). All patients will be (at minimum) contacted via visit at 30 days (±7 days) and at 12 months (±30 days), and by phone contact at 6 months (±14 days), 24 months (±30 days) and 36 months (±45 days) post index procedure to assess clinical status and adverse events. The Primary Endpoint for this trial is Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.
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
- •Male or female patient ≥18 years of age;
- •Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
- •Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
- •The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
- •Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.
排除标准
- •under 18 years of age;
- •Unable to sign written informed consent
- •Patient is a woman who is pregnant or nursing
- •Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
- •Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure;
- •Concurrent medical condition with a life expectancy of less than 3 years;
- •Currently participating in another trial and not yet at its primary endpoint
- •Active pathological bleeding;
- •History of intracranial haemorrhage.
- •OCT exclusion criteria
- •Left main lesion
- •Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
- •Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.
结局指标
主要结局
Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.
时间窗: 12 months post-procedure
PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (peri-procedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)
次要结局
- Rate of Individual components of patient-oriented composite endpoint;(1, 2 and 3 years post-procedure)
- Rate of Device-oriented composite endpoint (DoCE) at all timepoints;(30days, 6months, annually up to 3 years post procedure)
- Rate of Individual components of Target-vessel failure composite endpoint(30days, 6months, annually up to 3 years post procedure)
- Cost-Effectiveness(hospitalization, 1 year post procedure)
- Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years;(2 and 3 years post-procedure)
- Rate of Vessel-oriented composite endpoints (VoCE)(1, 2 and 3 years post-procedure)
- Rate of Individual components of device-oriented composite endpoint;(30days, 6months, annually up to 3 years post procedure)
- Rate of Individual components of vessel-oriented composite endpoint;(1, 2 and 3 years post-procedure)
- Rate of Stent thrombosis(30days, 6months, annually up to 3 years post procedure)
- Rate of Target-vessel failure composite endpoint(30days, 6months, annually up to 3 years post procedure)
- Rate of Pre-procedural myocardioal infarction according to 4th universal definition;(30days, 6months, annually up to 3 years post procedure)
- Device Success Rate(intra-operative)
- Rate of Net adverse clinical and cerebral events(30days, 6months, annually up to 3 years post procedure)
- Rate of Bleeding according to BARC (2, 3 and 5) classification(30days, 6months, annually up to 3 years post procedure)