Clinical trial NCT01689688: Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
Official title: Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are percutaenous coronary intervention and stenting and eligible to receive dual antiplatelet therapy at least more than 6 month.

Brief summary: The purpose of this study is to evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Older than 20 years old.
2. Indication of PCI.
3. To agree to review and record all the clinical course in this research protocol.
4. The patient who are eligible to receive dual antiplatelet therapy at least more than 6 month.
5. 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:

1. The patient who died during the research
2. The patient with Stent thrombosis during the research.
3. Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
4. Low ejection fraction (LVEF\<=30%), an impaired liver function, and renal dysfunction (eGFR\<=30)
5. The patient excluded from a safety of a thiazolidine derivative.

lesion exclusion criteria

1. left main artery
2. severe calcification
3. stent restenosis

Primary outcomes:
measure: The percentage of neointimal coverage
timeFrame: 12 months
Secondary outcomes:
measure: The percentage of neointimal coverage
timeFrame: 3 months
measure: The percentage of neointimal coverage
timeFrame: 6 months
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine
state: Hyogo
Study officials:
affiliation: Kobe University Graduate School of Medicine
name: Toshiro Shinke
role: PRINCIPAL_INVESTIGATOR
References: