Effect of TCFA on Neointimal Coverage After PCI at 9 Months Follow-up

Study Overview
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Brief Summary
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Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared with bare metal stents, late stent thrombosis (LST), a life-threatening complication of this technology, has emerged as a major concern. Researches indicated incomplete neointimal coverage of stent struts as the most important morphometric predictor of LST. Pathological research showed stenting disruption of adjacent vulnerable plaques can precipitate LST, Meanwhile, thin-cap fibroatheromas (TCFA) as the most important predictor of Major Adverse Cardiovascular. Therefore, there is a hypothesis that TCFA may impair intimal healing which are prone to LST in vivo. 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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The primary end point is to Neointimal coverage after 9 months of the stent implantation. 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.

Official Title
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Effect of TCFA on Neointimal Coverage After EXCEL Biodegradable Polymer-coated Sirolimus-eluting Stents Implantation at 9 Months Follow-up: Evaluated by Optical Coherence Tomography and Fractional Flow Reserve

Conditions
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Unrecognized Condition

Intervention / Treatment
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* Device: EXCEL biodegradable polymer-coated sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18yrs≤Age≤75yrs 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: AMI within 7 days. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TCFA<br>EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted on lesions which include TCFA (>=1) | Device: EXCEL biodegradable polymer-coated sirolimus-eluting stent<br> <br> |
| NO-TCFA<br>EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted on lesions which is not include TCFA | Device: EXCEL biodegradable polymer-coated sirolimus-eluting stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal coverage of EXCEL biodegradable polymer-coated sirolimus-eluting stent | offline OCT analysis will be performed independently by 2 investigators blinded to patient characteristics and to the stent used. Proprietary software will be used to analyze cross-sections at 1-mm intervals(every 5 frames) within the stented segment. In each cross-section, the number of struts was counted. Struts were classified as uncovered if any part of the strut was visibly exposed to the lumen, or covered if a layer of tissue was visible all over the reflecting surfaces. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular of EXCEL biodegradable polymer-coated sirolimus-eluting stent |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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national Cather Lad, Interventional Imaging Training Base