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Trial record 2 of 5 for:    21247313 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02384837
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces

Brief Summary:

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


Condition or disease Intervention/treatment
Unrecognized Condition Device: EXCEL biodegradable polymer-coated sirolimus-eluting stent

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : December 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016


Group/Cohort Intervention/treatment
TCFA
EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted on lesions which include TCFA (>=1)
Device: 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
Device: EXCEL biodegradable polymer-coated sirolimus-eluting stent



Primary Outcome Measures :
  1. Neointimal coverage of EXCEL biodegradable polymer-coated sirolimus-eluting stent [ Time Frame: 9 months ]
    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.


Secondary Outcome Measures :
  1. Major Adverse Cardiovascular of EXCEL biodegradable polymer-coated sirolimus-eluting stent [ Time Frame: 9 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will plan for a total of 55 patients with Non ST-ACS (all of the patients was selected in different blood vessels, a total of up to two target disease Variable and each target lesion 1 stents, such as placing stents need more than one in the operation, require the use of EXCEL stents, mix does not recommend the same patients Other brand support, unless save extra stents.) Choose lesions reference diameter of 2.5 mm to 4.0 mm (visual), each lesion length 32 mm or less (visual), participants must conform to the standard can be selected.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384837


Locations
China
Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China
Beijing, China, 100039
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
Study Chair: HUILIANG LIU, MD CHINESE ARMED POLICE FORCE GENRAL HOSPITAL

Publications of Results:

Other Publications:
Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT02384837     History of Changes
Other Study ID Numbers: Effect of TCFA
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: January 2015

Keywords provided by General Hospital of Chinese Armed Police Forces:
national Cather Lad
Interventional Imaging Training Base

Additional relevant MeSH terms:
Sirolimus
Everolimus
Chlorhexidine gluconate
Chlorhexidine
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents