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

Coronary Heart Disease Clinical Trial

— HEAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01689688
• Other study ID #: KobeU-001
• Secondary ID: R000008722
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2012
• Last updated: September 6, 2013
• Start date: September 2012
• Est. completion date: October 2015

Study information

• Verified date: September 2013
• Source: Kobe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of neointimal coverage	The primary endpoint is to evaluate the neointimal coverage of XIENCE everolimus eluting stent (EES) in 12 month after stent implantation by Optical coherence tomography	12 months	Yes
Secondary	The percentage of neointimal coverage		3 months	Yes
Secondary	The percentage of neointimal coverage		6 months	Yes