The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).
This is a prospective registry including patient scheduled for a clinically-indicated percutaneous coronary intervention (PCI) of a de novo epicardial lesion with indication for drug-eluting stent implantation. Following study enrolment and PCI/stent with the Angiolite DES, patients will be scheduled for follow-up surveillance coronary angiography and OCT with the C7-XRTM Fourier Domain OCT system with C7 DragonflyTM catheter (St Jude Medical, Minneapolis, MN) or with the Terumo LunawayTM OCT system with fastview catheter (Terumo Medical Corporation, Tokyo, Japan). An adaptive design component of the study will randomize patients to either 3-month or 6-month angio/OCT follow-up. Clinical follow-up will occur at 30 days, 3 months, 6 months, 12 months and 24 months post PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.
Hospital Vall D'Hebron
Barcelona, Spain
Hospital Universitario de Leon
León, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Neo-intimal coverage
Strut-based analysis: % of covered struts. Cross-sectional analysis: number of cross-sections with RUTTS (Rate of uncovered to total number of struts) score\>30%. Measured by an independant OCT laboratory
Time frame: 6-month
Neo-intimal obstruction
Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory
Time frame: 6-month
Neo-intimal coverage
Strut-based analysis: % of covered struts. Cross-sectional analysis: number of cross-sections with RUTTS (Rate of uncovered to total number of struts) score\>30%. Measured by an independant OCT laboratory.
Time frame: 3-month
Neo-intimal obstruction
Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory.
Time frame: 3-month
Apposition
Strut-based analysis: incomplete strut apposition (ISA) rate. Cross-sectional analysis: % frames with ISA. Measured by an independant OCT laboratory.
Time frame: 3- and 6-month
In-stent angiographic late lumen in mm
Confirmed by Imaging and measured by an independant QCA laboratory
Time frame: 6-month
In-stent and in-segment restenosis
Confirmed by Imaging and measured by an independant QCA laboratory (Reduction in percent diameter stenosis of stented segment of \>= 50%
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Time frame: 6-month
CV death
Death from any known cardiovascular etiology
Time frame: 6-month and 1-year
Myocardial infarction
Peri-procedural myocardial infarction will be defined according to the 3rd universal definition of MI Following PCI, myocardial infarction will be defined according to the specific clinical situation of the patient.
Time frame: Peri-procedural, spontaneous
Target-lesion revascularization
Any repeat revascularization du to a restenosis within the DES-treated segment
Time frame: 24 months
Binary restenosis
Reduction in percent diameter stenosis of stented segment of \< vs.\>= 50%
Time frame: 24 months