ILUMIEN III: OPTIMIZE PCI: OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 56
- 主要终点
- Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)
研究概览
简要总结
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
详细描述
This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.
Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.
After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
For those subjects randomized to the IVUS or Angiography treatment arms, the operating investigator at the site was blinded to the final post-PCI OCT run for the subject.
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
- •Age ≥ 18 years.
- •Patient with an indication for PCI including:
- •Angina (stable or unstable),
- •Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present),
- •NSTEMI, or
- •Recent STEMI (>24 hours from initial presentation and stable).
- •Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
- •Signed written informed consent
- •Angiographic inclusion criteria:
- •The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤3.50 mm.
- •Lesion length <40mm
排除标准
- •Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis
- •STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.
- •PCI within 24 hours preceding the study procedure.
- •PCI of a lesion within the target vessel within 12 months prior to the study procedure
- •Planned use of bare metal stent (BMS)
- •Planned use of bioresorbable vascular scaffold (BVS)
- •Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP, at time of procedure.
- •Mobitz II second degree or complete heart block
- •Malignant ventricular arrhythmias requiring treatment
- •Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema
- •Subject is intubated.
- •Known LVEF <30%.
- •Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
- •Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
- •Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes.
- •Known allergy to protocol-required concomitant medications including aspirin; clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast that cannot be adequately pre-medicated.
- •Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
- •Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment).
- •Angiographic Exclusion Criteria:
- •The presence of any non-study lesion in the target vessel with angiographic diameter stenosis >50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure
- •Left main diameter stenosis ≥30% or left main PCI planned.
- •Study target lesion in a bypass graft
- •Ostial RCA study target lesion
- •Chronic total occlusion (TIMI flow 0/1) study target lesion
- •Bifurcation study lesion with a planned dual stent strategy
- •In-stent restenosis study target lesion
- •Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)
结局指标
主要结局
Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)
时间窗: Post-procedure within 1 hour
Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows: 1. Non-inferiority: OCT vs. IVUS guided stenting Non-inferiority of OCT guided stenting to IVUS guided stenting will be analyzed for the mean difference between the post PCI MSA for the OCT and IVUS arms with non-inferiority margin of 1.0 mm\^2. 2. Superiority: OCT vs. Angiography guided stenting If the OCT guided stenting arm was found to be non-inferior to the IVUS guided stenting arm, the superiority of OCT to angiography will be tested for the mean difference between the post PCI MSA for the OCT and angiography arms. 3. Superiority: OCT vs. IVUS guided stenting If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms.
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event)
时间窗: During procedure, an average of 1 hour
Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, pericardiocentesis, thrombus aspiration and other).
次要结局
- Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention(Final Post-PCI, up to 1 hour after PCI procedure)
- Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B(Final Post-PCI, up to 1 hour after PCI procedure)
- Number of Participants With Acute Procedural Success(During procedure, an average of 1 hour)
- Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run(During procedure, an average of 1 hour)
- IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only)(During procedure, an average of 1 hour)
- Rate of Post-PCI Stent Expansion (%)(Up to 1 hour post-procedure)
- Rate of Mean Stent Expansion (%)(During procedure, an average of 1 hour)
- Number of Participants With Untreated Reference Segment Disease(During procedure, an average of 1 hour)
- Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter(Final Post-PCI, up to 1 hour after PCI procedure)
- Procedural Endpoints (Site Reported): Median Stents Per Lesion(During procedure, an average of 1 hour)
- Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions(During procedure, an average of 1 hour)
- Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction(1 Year)
- Number of Participants With Plaque Protrusion and Thrombus(During procedure, an average of 1 hour)
- Number of Participants With Stent Malapposition(During procedure, an average of 1 hour)
- Median Effective Lumen Area (Total Flow Area)(Up to 1 hour post-procedure)
- IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only)(During procedure, an average of 1 hour)
- Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio(Final Post-PCI, up to 1 hour after PCI procedure)
- Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations(During procedure, an average of 1 hour)
- Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)(During procedure, an average of 1 hour)
- Number of Participants With Edge Dissections(During procedure, an average of 1 hour)
- Number of Participants With Border Detection (OCT Arm Only)(Pre-PCI OCT Run procedure)
- Median Intra-stent Lumen Area (Intra-stent Flow Area)(Up to 1 hour post-procedure)
- IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only)(During procedure, an average of 1 hour)
- Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis(Final Post-PCI, up to 1 hour after PCI procedure)
- Procedural Endpoints (Site Reported) - Median Maximal Stent Size(During procedure, an average of 1 hour)
- Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate(During procedure, an average of 1 hour)
- Procedural Endpoints (Site Reported): Median Total Stent Length(During procedure, an average of 1 hour)
- Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate(During procedure, an average of 1 hour)
- Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF)(1 year)