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

December 4, 2016 updated by: General Hospital of Chinese Armed Police Forces

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100039
        • Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Chinese Armed Police Forces

Investigators

  • Study Chair: HUILIANG LIU, MD, CHINESE ARMED POLICE FORCE GENRAL HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 25, 2014

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 4, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effect of TCFA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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