Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System: a Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Clear stent capture rate (CSCR)
研究概览
简要总结
Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were all recommended for percutaneous coronary intervention (PCI) optimization in the latest guidelines, however, which imaging modality was more suitable as either a diagnostic or guidance tool was still unknown. Recently, a novel, well-designed hybrid imaging system was approved for clinical use, allowing the accurate co-registration of two imaging modalities and immediate, simultaneous image review. For testing each modality in the hybrid imaging system, the investigators conducted this prospective, multicentre, non-inferiority trial. In this study, all participants achieved hybrid IVUS-OCT imaging after stenting, at meanwhile, patients randomly assigned to the IVUS arm were performed control IVUS (OptiCross, Boston Scientific, Natick, MA), and patients randomly assigned to the OCT arm were performed control OCT (C7 Dragonfly Duo, St. Jude Medical, St. Paul, MN). In this study, the investigators evaluated the non-inferiority of standalone IVUS versus control IVUS or standalone OCT versus control OCT in clinical feasibility using clear stent capture rate (CSCR) and safety using perioperative device-related adverse cardiovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Patients eligible for elective percutaneous coronary intervention
- •Understand and voluntarily sign the informed consent form
排除标准
- •The lesion-related exclusion criteria:
- •More than 1 stent was planned to deploy in culprit lesion
- •In-stent restenosis
- •Bifurcation lesion with proposed double stent implantation
- •The length of the reference vessel segment proximal or distal to the lesion was less than 5mm
- •The length of the implanted stent was larger than 33mm
- •The diameter of reference vessel was less than 2 mm or larger than 4 mm
- •Lesions were in left main or ostium of right coronary artery
- •The distance between either end of the lesion and the lateral branches larger than 2 mm in diameter was less than 5 mm
- •Angiography revealed thrombosis in culprit vessel
- •Severely calcified lesions or tortuous coronary arteries
- •Decreased blood flow (thrombolysis in myocardial infarction score ≤ 2)
- •Patients-level exclusion criteria:
- •Breastfeeding or pregnant women, the subject (or his partner) who had a pregnancy plan during the trial or within 6 months after the end of the trial, and subject who did not agree to use contraception during the trial
- •Participants who had withdrawn from other clinical studies within 3 months or are participating in other clinical trials
- •Acute myocardial infarction occurred within one week prior to screening
- •Cardiac troponin I or cardiac troponin T levels exceed the upper limit of normal reference values within 72 hours of procedure and were of clinical significance
- •Renal insufficiency with creatinine > 200μmol/L
- •Unsuitable for coronary artery bypass grafting (CABG)
- •Unsuitable for percutaneous coronary intervention;
- •Coronary spasm
- •Chronic total occlusion or subtotal occlusion
- •Severe hemodynamic disturbances or shock
- •History of CABG
- •Coagulation is abnormal and clinically significant
- •Severe heart failure (NYHA III, IV or Left ventricular ejection fraction < 30%)
- •History of contrast allergy
- •Multi-vessel disease
- •Chemotherapy or planned chemotherapy
- •Investigators consider unsuitable for participants selected for this study
结局指标
主要结局
Clear stent capture rate (CSCR)
时间窗: During the procedure
The CSCR detected was defined as the ratio of the clear stent length to the total stent length
次要结局
- Detection rate of edge dissection, tissue prolapse and stent malapposition(During the procedure)
- Device success rate(During the procedure)
- Adverse procedure-related adverse cardiovascular events(Periprocedure)
- Proportion of patients with clear image length ≥ 24mm(During the procedure)
研究者
Yu Bo
Director of Department of Cardiology
The Second Affiliated Hospital of Harbin Medical University