Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Angiolite stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angiolite stent - 3-month angiogram/OCT<br>Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 3-month post index PCI. | Device: Angiolite stent<br>* 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.<br>* Other names: (Angiolite CE Mark reference number: 2014 12 0833 ED);|
| Experimental: Angiolite stent - 6-month angiogram/OCT<br>Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 6-month post index PCI. | Device: Angiolite stent<br>* 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.<br>* Other names: (Angiolite CE Mark reference number: 2014 12 0833 ED);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6-month | 
| Neo-intimal obstruction | Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory | 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3-month | 
| Neo-intimal obstruction | Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory. | 3-month | 
| Apposition | Strut-based analysis: incomplete strut apposition (ISA) rate. Cross-sectional analysis: % frames with ISA. Measured by an independant OCT laboratory. | 3- and 6-month | 
| In-stent angiographic late lumen in mm | Confirmed by Imaging and measured by an independant QCA laboratory | 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% | 6-month | 
| CV death | Death from any known cardiovascular etiology | 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. | Peri-procedural, spontaneous | 
| Target-lesion revascularization | Any repeat revascularization du to a restenosis within the DES-treated segment | 24 months | 
| Binary restenosis | Reduction in percent diameter stenosis of stented segment of < vs.>= 50% | 24 months |