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
  Purpose

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.


Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Kobe University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
EES-XIENCE V
Groups who were treated with XIENCE V® everolimus eluting stent

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689688

Locations
Japan
Kobe University Graduate School of Medicine Recruiting
Kobe, Hyogo, Japan
Contact: Toshiro Shinke, MD, PhD    +81.78.382.5846    shinke@med.kobe-u.ac.jp   
Principal Investigator: Toshiro Shinke, MD, PhD         
Sponsors and Collaborators
Kobe University
Investigators
Principal Investigator: Toshiro Shinke Kobe University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Toshiro Shinke, MD, PhD, Associate Professor, Kobe University
ClinicalTrials.gov Identifier: NCT01689688     History of Changes
Other Study ID Numbers: KobeU-001, R000008722
Study First Received: September 7, 2012
Last Updated: September 6, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 28, 2014