NCT05241665已完成不适用
A First in Human Study of the SpectraWAVE Imaging System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility Evaluation
研究概览
简要总结
Investigational, prospective, multi-site, first in human, feasibility evaluation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject must be at least 18 years of age.
- •Patient with an indication for percutaneous coronary intervention (PCI) including:
- •Angina (stable or unstable),
- •Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or fractional flow reserve (FFR) ≤0.80 or iFR ≤0.89 must be present),
- •Non-ST-elevation myocardial infarction (NSTEMI), or
- •Recent ST-Segment Elevation Myocardial Infarction (STEMI) (>48 hours from initial presentation and stable).
- •Patients will undergo cardiac catheterization and possible or definite PCI.
- •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 ≤5.2 mm and diameter stenosis of ≥50% but <100%.
- •Lesion length <40 mm.
排除标准
- •Serum creatinine ≥ 2.5 mg/dL Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine.
- •STEMI within 48 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 6 months prior to the study procedure.
- •Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including an Intra-Aortic Balloon Pump, at time of procedure.
- •Mobitz II second degree or complete heart block.
- •Unstable ventricular arrhythmias
- •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.
- •Left ventricular ejection fraction (LVEF) ≤30% by the most recent imaging test within 3 months prior to procedure. If no LVEF test result within 3 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
- •Severe valvular disease (e.g., severe mitral regurgitation or severe aortic stenosis)
- •Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past 6 months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
- •Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- •Note: femoral arterial disease does not exclude the patient if radial access may be used.
- •Presence of 1 or more co-morbidities which reduces life expectancy to less than 6 months or may interfere with protocol study processes.
- •Subject has known hypersensitivity or contraindication to radiocontrast dye that cannot be adequately pre-medicated.
- •Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
- •Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm
- •Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- •Subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past 6 months.
- •Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint.
- •Women who are pregnant or breastfeeding
- •Women of childbearing potential unless a pregnancy test is negative within 1 week before study procedure.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or impact the scientific soundness of the clinical investigation results.
- •Angiographic Exclusion Criteria:
- •Left main diameter stenosis ≥30% or left main PCI planned.
- •Study target lesion in a bypass graft.
- •The target lesion is an ostial right coronary artery (RCA) stenosis.
- •Chronic total occlusion (Thrombolysis in Myocardial Infarction (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 catheter to the lesion pre and post PCI (e.g., moderate or severe vessel calcification or tortuosity).
- •The target lesion contains more than a small amount of thrombus (as assessed angiographically) or is a stent thrombosis.
- •Inclusion Criteria:
- •Subject must be at least 18 years of age.
- •Patient must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI.
- •Patients undergoing a clinically indicated PCI procedure meeting 1 or more of the following criteria:
- •A) High clinical risk, defined as medication-treated diabetes mellitus, AND/OR B) High angiographic-risk lesion(s), with at least 1 target lesion in each target vessel meeting at least 1 of the following criteria; i. Target lesion is the culprit lesion responsible for either:
- •NSTEMI, defined as a clinical syndrome consistent with an acute coronary syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to normal), OR
- •STEMI >48 hours from the onset of ischemic symptoms ii. long or multiple lesions (defined as intended total stent length in any single target vessel ≥28 mm), Note: For a long target lesion, this would permit treatment by a single long stent or overlapping stents.
- •Note: For up to 2 target lesions located in a single target vessel and treated with non-overlapping stents, they may be located in a continuous vessel or split up between a main vessel and a side branch.
- •iii. bifurcation intended to be treated with 2 planned stents (i.e., in both the main branch and side branch), and where the planned side branch stent is ≥ 2.5 mm in diameter by angiographic visual estimation, iv. angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion), v. chronic total occlusion (CTO) (enrollment in this case performed only after successful antegrade wire escalation crossing and pre-dilatation), vi. in-stent restenosis of diffuse or multi-focal pattern. Lesion must be at or within the existing stent margin(s) and have angiographically visually assessed DS ≥70% or DS ≥50% with non-invasive or invasive evidence of ischemia.
- •All target lesions must have a visually estimated or quantitatively assessed %DS of either ≥70%, or ≥50% plus 1 or more of the following: an abnormal functional test (e.g., FFR, instantaneous wave-free ratio (iFR), stress test) signifying ischemia in the distribution of the target lesion(s) or biomarker positive acute coronary syndrome (ACS) with plaque disruption or thrombus.
- •Note: For purposes of study eligibility, a minimum troponin of 1 ng/dL at the time of screening will be considered biomarker positive.
- •No more than 2 target lesions requiring PCI are present in any single vessel, and no more than 2 target vessels are allowed. Thus, up to 4 target lesions per patient in a maximum of 2 target vessels are allowed, including branches.
- •Note: A lesion is defined as any segment(s) of the coronary tree, no matter how long, which is planned to be covered with 1 contiguous length of stent, whether single or overlapped. A bifurcation counts as a single lesion even if the side branch is planned to be treated.
- •Note: All lesions in a target vessel that are intended to be treated by PCI are designated as target lesions, and at least 1 target lesion in each target vessel must meet angiographic high-risk inclusion criteria summarized above in 3B). The only exception is for patients who qualify for the trial based on medication-treated diabetes, in which case no target lesion is required to meet angiographic high-risk inclusion criteria.
- •All target lesions intended to be treated by PCI in the target vessel are amenable to imaging guided PCI.
- •Example: If a qualifying angiographic high-risk lesion is in the proximal LAD, and there is a second target lesion in the distal LAD which is a focal lesion not otherwise meeting high-risk criteria, both the proximal LAD and distal LAD lesions must be amenable to intravascular imaging (e.g., no excessive tortuosity or calcification precluding delivering the catheter), and each lesion must undergo imaging guided stenting. Otherwise, the vessel should be excluded.
- •Subject must provide written Informed Consent prior to any study related procedure.
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结局指标
主要结局
Feasibility Evaluation
时间窗: From informed consent to hospital discharge after the SpectraWAVE Imaging System procedure, an average of less than one day.
The primary endpoint is the feasibility evaluation of the SpectraWAVE Imaging System to successfully image the native coronary artery as measured by questionnaire.
次要结局
- Safety Evaluation(From informed consent to 30-Day Follow-Up Visit after the SpectraWAVE Imaging System procedure.)
研究者
研究点 (1)
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