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

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

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.

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