An Optical Coherence Tomography Evaluation of the Effects of High-Pressure, Non-compliant Ballooning on Scaffold Embedding
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the percentage of the number of embedded scaffold struts as evaluated by OCT
研究概览
简要总结
This study is a single-center, prospective, observational study designed to subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions.
Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.
详细描述
This study is a single-center, prospective, observational study designed to enroll 50 subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Consented subjects are to undergo PCI and have a lesion without angiographic calcification.
Eligible subjects who meet inclusion and exclusion criteria for BVS scaffold implant will have a BVS-specific implantation protocol with high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. Because the scaffold is compliant, a perfectly embedded scaffold is sometimes observed in a lesion with soft plaque, resulting in a smaller intra-luminal scaffold volume that may reduce the event rate. Enrolled subjects will have OCT ( optical coherence tomography ) pre and post BVS implantation to assess the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation (using the moderate pressure of 12 atm) to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years who undergo PCI of de novo lesions in the setting of stable angina or acute coronary syndromes.
- •The culprit lesion must be successfully pre-dilated prior to enrollment. -
排除标准
- •I. Patient specific
- •Cardiogenic shock (sustained [>10 min] systolic blood pressure <90 mm Hg in absence of inotropic support or the presence of an intra-aortic balloon pump support).
- •Known severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.72 m2).
- •Intolerance of aspirin or thienopyridines
- •ST-segment elevation myocardial infarction
- •Subject is a woman of childbearing potential, pregnant, or nursing.
- •Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
- •Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, ticagrelor or prasugrel, or to everolimus, PLLA polymers, or contrast sensitivity that cannot be adequately pre-medicated.
- •Subject has a platelet count <100,000 cell/mm3 or >700,000 cell/mm3, a white blood cell count of <3,000 cell/mm3, or documented or suspected liver disease in the recent blood test.
- •II. Lesion specific
- •Left main disease defined as diameter stenosis >50%
- •Ostial lesion
- •Tortuous artery in which OCT is unable to pass
- •Lesion in a bypass graft
- •Reference vessel diameter (RVD) <2.5 mm or >4 mm
- •Bifurcation lesions with side branches >2 mm
- •In-stent restenosis
- •Previous placement of a stent proximal or distal to or within 10 mm of the target lesion
- •Chronic total occlusion
- •Lesions with calcified plaque >180° by pre-intervention OCT
结局指标
主要结局
Change in the percentage of the number of embedded scaffold struts as evaluated by OCT
时间窗: intra-procedure (PCI)
Percentage of embedded scaffold strut is defined as the ratio of the number of embedded strut to the total number of analyzed strut per lesion. (% of embedded scaffold struts = No. of embedded struts / total No. of analyzed struts) The analysis will be done for both OCT images 1) after initial bioresorbable scaffold implantation using moderate pressure and 2) after post-dilatation using high pressure non-compliant balloon, and the change in percentage of embedded scaffold strut from initial bioresorbable scaffold implantation to post-dilation will be calculated. (∆ % of embedded scaffold struts = % of embedded scaffold struts of initial scaffold implantation - % of embedded scaffold struts of post-dilatation)
次要结局
- Change in minimum scaffold cross-sectional area(intra-procedure (PCI))
- Change in the ratio of minimum scaffold cross-sectional area and average of proximal and distal reference lumen cross-sectional(intra-procedure (PCI))
- Change in the Percentage of footprint(intra-procedure (PCI))
- Change in mean scaffold cross-sectional area(intra-procedure (PCI))
- Change in the ratio of minimum scaffold cross-sectional area and expected scaffold cross-sectional area from manufacturer chart of balloon(intra-procedure (PCI))
- Comparison of scaffold embedding between non-calcified plaque and moderate calcified plaque (arc <180°)(intra-procedure (PCI))
研究者
Richard A. Shlofmitz, MD
Chairman of Cardiology
St. Francis Hospital, New York