Coronary Heart Disease
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEAngiolite stent
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.
Sponsors
iVascular
Josep Rodes-Cabau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for clinically-indicated PCI of a de nove epicardial lesion, including those with chronic stable angina, ACS (defined as NSTEMI or ACS with negative cardiac enzymes) or in the setting of elective PCI. * Indication for DES implantation * Target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia * Strong preference for single stent coverage per lesion, but if unexpected clinically indicated second stent placement with overlap is needed, these patients will not be excluded from optical coherence tomographic follow-up * Target lesion, if possible, should be predilated/pretreated
Exclusion criteria
* Age \>85 years * Acute ST segment elevation MI (STEMI) * Cardiogenic shock * Known left ventricular ejection fraction \<30% * Contraindication for dual antiplatelet therapy (DAPT) for at least 6-month duration * Iodinated contrast allergy * Renal impairment with serum creatinine \>2.0 mg/dL * Anticipated medical non-compliance * Life-expectancy \<12 months * Chronic total occlusion (CTO) in the target vessel * Bifurcation lesion requiring a two-stent strategy * In-stent restenosis * Severe lesion/segment angulation/tortuosity * Severe vessel/lesion calcification * Simultaneous PCI within the same or different vessel during the same procedure * Lesion unsuitable for OCT (proximal lesions \<10 mm from ostium of left main or right coronary arteries) * Lesion length \>18 mm * Stent length \>24 mm * Stent diameter ≤2.5 mm and \> 4.0 mm * Unprotected left main coronary artery disease (≥50% diameter stenosis) * \>1 lesion * Planned use of 2 overlapping stents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neo-intimal coverage | 6-month | 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 |
| Neo-intimal obstruction | 6-month | Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apposition | 3- and 6-month | Strut-based analysis: incomplete strut apposition (ISA) rate. Cross-sectional analysis: % frames with ISA. Measured by an independant OCT laboratory. |
| In-stent angiographic late lumen in mm | 6-month | Confirmed by Imaging and measured by an independant QCA laboratory |
| In-stent and in-segment restenosis | 6-month | Confirmed by Imaging and measured by an independant QCA laboratory (Reduction in percent diameter stenosis of stented segment of \>= 50% |
| Neo-intimal coverage | 3-month | 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. |
| Myocardial infarction | Peri-procedural, spontaneous | 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. |
| Target-lesion revascularization | 24 months | Any repeat revascularization du to a restenosis within the DES-treated segment |
| Binary restenosis | 24 months | Reduction in percent diameter stenosis of stented segment of \< vs.\>= 50% |
| CV death | 6-month and 1-year | Death from any known cardiovascular etiology |
| Neo-intimal obstruction | 3-month | Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory. |
Countries
Spain
Outcome results
None listed