OCT and Scaffold Embedding After NC Balloon

Status unconfirmed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT03106961

Run by

St. Francis Hospital, New York

People needed

50

Starts

2017-03-30

Expected to finish

2018-06-30

Last updated by the study team

2017-04-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. -

You may not qualify if…

• 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

Where it is running

• St Francis Hospital — Roslyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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