Clinical trial NCT02776267: Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study
Official title: Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
Collaborators: name: iVascular
First posted: 2016-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Neo-intimal coverage
timeFrame: 6-month
measure: Neo-intimal obstruction
timeFrame: 6-month
Secondary outcomes:
measure: Neo-intimal coverage
timeFrame: 3-month
measure: Neo-intimal obstruction
timeFrame: 3-month
measure: Apposition
timeFrame: 3- and 6-month
measure: In-stent angiographic late lumen in mm
timeFrame: 6-month
measure: In-stent and in-segment restenosis
timeFrame: 6-month
measure: CV death
timeFrame: 6-month and 1-year
measure: Myocardial infarction
timeFrame: Peri-procedural, spontaneous
measure: Target-lesion revascularization
timeFrame: 24 months
measure: Binary restenosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Leon
country: Spain
facility: Hospital Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Josep Rodes-Cabau, MD
role: PRINCIPAL_INVESTIGATOR
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