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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Kobe University
Sponsor:
Information provided by (Responsible Party):
Toshiro Shinke, MD, PhD, Kobe University
ClinicalTrials.gov Identifier:
NCT01689688
First received: September 7, 2012
Last updated: September 6, 2013
Last verified: September 2013

September 7, 2012
September 6, 2013
September 2012
September 2013   (final data collection date for primary outcome measure)
The percentage of neointimal coverage [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01689688 on ClinicalTrials.gov Archive Site
  • The percentage of neointimal coverage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • The percentage of neointimal coverage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The percentage of neointimal coverage [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients who are percutaenous coronary intervention and stenting and eligible to receive dual antiplatelet therapy at least more than 6 month.

Coronary Heart Disease
Not Provided
EES-XIENCE V
Groups who were treated with XIENCE V® everolimus eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2015
September 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Japan
 
NCT01689688
KobeU-001, R000008722
Yes
Toshiro Shinke, MD, PhD, Kobe University
Kobe University
Not Provided
Principal Investigator: Toshiro Shinke Kobe University Graduate School of Medicine
Kobe University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP