Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Angiolite stent - 3-month angiogram/OCT 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
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.
Other Names:
|
| Experimental: Angiolite stent - 6-month angiogram/OCT 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 laboratory
- Neo-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
- 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%
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Indication for DES implantation
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Target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia
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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
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Target lesion, if possible, should be predilated/pretreated
Exclusion Criteria:
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Age >85 years
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Acute ST segment elevation MI (STEMI)
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Cardiogenic shock
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Known left ventricular ejection fraction <30%
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Contraindication for dual antiplatelet therapy (DAPT) for at least 6-month duration
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Iodinated contrast allergy
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Renal impairment with serum creatinine >2.0 mg/dL
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Anticipated medical non-compliance
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Life-expectancy <12 months
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Chronic total occlusion (CTO) in the target vessel
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Bifurcation lesion requiring a two-stent strategy
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In-stent restenosis
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Severe lesion/segment angulation/tortuosity
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Severe vessel/lesion calcification
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Simultaneous PCI within the same or different vessel during the same procedure
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Lesion unsuitable for OCT (proximal lesions <10 mm from ostium of left main or right coronary arteries)
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Lesion length >18 mm
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Stent length >24 mm
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Stent diameter ≤2.5 mm and > 4.0 mm
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Unprotected left main coronary artery disease (≥50% diameter stenosis)
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1 lesion
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Planned use of 2 overlapping stents
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Vall D'Hebron | Barcelona | Spain | ||
| 2 | Hospital Universitario de Leon | Leon | Spain | ||
| 3 | Hospital Clinico San Carlos | Madrid | Spain | ||
| 4 | Hospital Universitario Marqués de Valdecilla | Santander | Spain |
Sponsors and Collaborators
- Josep Rodes-Cabau
- iVascular
Investigators
- Principal Investigator: Josep Rodes-Cabau, MD, Institut universitaire de cardiologie et de pneumologie de Québec
Study Documents (Full-Text)
None provided.More Information
Publications
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- Prati F, Romagnoli E, Valgimigli M, Burzotta F, De Benedictis M, Ramondo A, Mehran R, Stella PR. Randomized comparison between 3-month Cre8 DES vs. 1-month Vision/Multilink8 BMS neointimal coverage assessed by OCT evaluation: the DEMONSTRATE study. Int J Cardiol. 2014 Oct 20;176(3):904-9. doi: 10.1016/j.ijcard.2014.08.031. Epub 2014 Aug 13.
- Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Mintz GS, Gao RL. Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial. EuroIntervention. 2014 Nov;10(7):806-14. doi: 10.4244/EIJY14M07_17.
- Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hébert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.
- Suzuki Y, Ikeno F, Koizumi T, Tio F, Yeung AC, Yock PG, Fitzgerald PJ, Fearon WF. In vivo comparison between optical coherence tomography and intravascular ultrasound for detecting small degrees of in-stent neointima after stent implantation. JACC Cardiovasc Interv. 2008 Apr;1(2):168-73. doi: 10.1016/j.jcin.2007.12.007.
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- Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons, Thygesen K, Alpert JS, White HD; Biomarker Subcommittee, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA; ECG Subcommittee, Chaitman BR, Clemmensen PM, Johanson P, Hod H; Imaging Subcommittee, Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ; Classification Subcommittee, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW; Intervention Subcommittee, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J; Trials & Registries Subcommittee, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML; Trials & Registries Subcommittee, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G; Trials & Registries Subcommittee, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D; Trials & Registries Subcommittee, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG), Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers, Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012 Oct 16;60(16):1581-98. doi: 10.1016/j.jacc.2012.08.001. Epub 2012 Sep 5.
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- ANCHOR