Effect of TCFA on Neointimal Coverage After PCI at 9 Months Follow-up
NCT ID: NCT02384837
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2014-12-31
2016-11-30
Brief Summary
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Optical coherence tomography (OCT)is a high-resolution (\<10 µm), catheter-based imaging modality capable of investigating detailed coronary plaque morphology in vivo.This study aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts on the lesions which fractional flow reserve (FFR)≤0.75 after EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted at 9 months follow up: evaluated by OCT and FFR
Detailed Description
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Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TCFA
EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted on lesions which include TCFA (\>=1)
EXCEL biodegradable polymer-coated sirolimus-eluting stent
NO-TCFA
EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted on lesions which is not include TCFA
EXCEL biodegradable polymer-coated sirolimus-eluting stent
Interventions
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EXCEL biodegradable polymer-coated sirolimus-eluting stent
Eligibility Criteria
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Inclusion Criteria
* stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed myocardial ischemia
* De novo lesion at native coronary artery(Up to two target lesions)
* Lesion length ≤32mm
* RVD 2.5mm～4.0mm
* DS%≥70% by visual test
* Coronary artery bypass surgery (coronary artery bypass grafting) patients
* Subjects are willing to follow the specified requirements follow-up
* To understand the purpose of the trial and willing to sign informed consent and accept clinical follow-up
Exclusion Criteria
* CTO (TIMI 0), the left main lesion, ostial lesion and transplant vascular lesions, the bifurcation lesion (reference collateral blood vessel diameter of 2.5 mm or higher), stent restenosis lesions and to deal with three pathological changes;
* Severe calcified lesion unable to predilate.
* The distortion of the stent was hampered by lesions.
* NYHA≥Ⅲ or LVEF\<40%.
* Prior PCI within 1 year.
* Pregnancy or lactation, and planning pregnancy or lactation.
* Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
* There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (\< 1 year).
* To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
* Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
* Before enrolling to participate in other clinical trials and not reached the primary endpoint.
* Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.
18 Years
75 Years
ALL
No
Sponsors
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General Hospital of Chinese Armed Police Forces
OTHER
Responsible Party
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Principal Investigators
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HUILIANG LIU, MD
Role: STUDY_CHAIR
CHINESE ARMED POLICE FORCE GENRAL HOSPITAL
Locations
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Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China
Beijing, , China
Countries
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References
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Ozaki Y, Okumura M, Ismail TF, Naruse H, Hattori K, Kan S, Ishikawa M, Kawai T, Takagi Y, Ishii J, Prati F, Serruys PW. The fate of incomplete stent apposition with drug-eluting stents: an optical coherence tomography-based natural history study. Eur Heart J. 2010 Jun;31(12):1470-6. doi: 10.1093/eurheartj/ehq066. Epub 2010 Apr 2.
Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.
Kubo T, Imanishi T, Kitabata H, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Takarada S, Tanaka A, Nakamura N, Mizukoshi M, Tomobuchi Y, Akasaka T. Comparison of vascular response after sirolimus-eluting stent implantation between patients with unstable and stable angina pectoris: a serial optical coherence tomography study. JACC Cardiovasc Imaging. 2008 Jul;1(4):475-84. doi: 10.1016/j.jcmg.2008.03.012.
Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
Farb A, Burke AP, Kolodgie FD, Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation. 2003 Oct 7;108(14):1701-6. doi: 10.1161/01.CIR.0000091115.05480.B0. Epub 2003 Sep 22.
Guagliumi G, Sirbu V, Musumeci G, Bezerra HG, Aprile A, Kyono H, Fiocca L, Matiashvili A, Lortkipanidze N, Vassileva A, Popma JJ, Allocco DJ, Dawkins KD, Valsecchi O, Costa MA. Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI). Circ Cardiovasc Interv. 2010 Aug;3(4):367-75. doi: 10.1161/CIRCINTERVENTIONS.110.950154. Epub 2010 Jul 20.
Other Identifiers
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Effect of TCFA
Identifier Type: -
Identifier Source: org_study_id