Suspended

HEALHealing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases+2

+ Heart Diseases

+ Vascular Diseases

Over 20 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorKobe University
Study ContactToshiro Shinke, MD, PhDMore contacts
Last updated: September 9, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Late and very late stent thrombosis is current main issue after introduction of drug-eluting stents .Possible causes of these stent thromboses include thrombus formation resulting from delayed neointimal coverage, spasms occurring at the distal end of the stent implantation site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal coverage begins within the first one month after stent implantation and almost completes in three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is markedly delayed after stent implantation and the exposed stent struts may be largely attributable to the occurrence of late stent thrombosis. On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer and improved polymer biocompatibility, it has been reported that earlier and more normal neointimal coverage can be achieved compared with other first-generation DESs, SES and paclitaxel eluting stents (PES). These findings suggest that coverage with vascular endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate cross-sectional images of the stent struts covered with vascular endothelium. However, no studies have reported the results of continuous observation and evaluation of EES covered with endothelium. Therefore, the investigators investigate time course of neointimal coverage of EES through detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent implantation.

NCT01689688
Principal SponsorKobe University
Study ContactToshiro Shinke, MD, PhDMore contacts
Last updated: September 9, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Disease

Criteria

Inclusion Criteria: Older than 20 years old. Indication of PCI. To agree to review and record all the clinical course in this research protocol. The patient who are eligible to receive dual antiplatelet therapy at least more than 6 month. Informed concent with the document signed by the patients. The patient have to correspond to all the above items at the time of registration. Exclusion Criteria: The patient who died during the research The patient with Stent thrombosis during the research. Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug. Low ejection fraction (LVEF<=30%), an impaired liver function, and renal dysfunction (eGFR<=30) The patient excluded from a safety of a thiazolidine derivative. lesion exclusion criteria left main artery severe calcification stent restenosis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Kobe University Graduate School of Medicine

Kobe, JapanOpen Kobe University Graduate School of Medicine in Google Maps
SuspendedOne Study Center