Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study
- Conditions
- Coronary Heart Disease
- Interventions
- Device: Angiolite stent
- Registration Number
- NCT02776267
- Lead Sponsor
- Josep Rodes-Cabau
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiolite stent - 6-month angiogram/OCT Angiolite stent 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. Angiolite stent - 3-month angiogram/OCT Angiolite stent 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.
- Primary Outcome Measures
Name Time Method 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 laboratoryNeo-intimal obstruction 6-month Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory
- Secondary Outcome Measures
Name Time Method 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.Neo-intimal obstruction 3-month Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory.
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%
CV death 6-month and 1-year Death from any known cardiovascular etiology
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%
Trial Locations
- Locations (4)
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de Leon
🇪🇸Leon, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain