Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Josep Rodes-Cabau
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Neo-intimal coverage
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Josep Rodes-Cabau
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Eligibility Criteria
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
Outcomes
Primary Outcomes
Neo-intimal coverage
Time Frame: 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
Time Frame: 6-month
Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory
Secondary Outcomes
- Neo-intimal coverage(3-month)
- Neo-intimal obstruction(3-month)
- Apposition(3- and 6-month)
- In-stent angiographic late lumen in mm(6-month)
- In-stent and in-segment restenosis(6-month)
- CV death(6-month and 1-year)
- Myocardial infarction(Peri-procedural, spontaneous)
- Target-lesion revascularization(24 months)
- Binary restenosis(24 months)