oct and scaffold embedding after nc balloon

Conditions: Coronary Artery Disease

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: 1. patients ≥18 years who undergo pci of de novo lesions in the setting of stable angina or acute coronary syndromes. 2. the culprit lesion must be successfully pre-dilated prior to enrollment. - exclusion criteria: i. patient specific 1. 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). 2. known severe renal insufficiency (estimated glomerular filtration rate \<30 ml/min/1.72 m2). 3. intolerance of aspirin or thienopyridines 4. st-segment elevation myocardial infarction 5. subject is a woman of childbearing potential, pregnant, or nursing. 6. subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant. 7. 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. 8. subject has a platelet count \ 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 1. left main disease defined as diameter stenosis \>50% 2. ostial lesion 3. tortuous artery in which oct is unable to pass 4. lesion in a bypass graft 5. reference vessel diameter (rvd) \ 4 mm 6. bifurcation lesions with side branches \>2 mm 7. in-stent restenosis 8. previous placement of a stent proximal or distal to or within 10 mm of the target lesion 9. chronic total occlusion 10. lesions with calcified plaque \>180° by pre-intervention oct