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

NCT01689688 | Unknown DMC

• 2 other identifiers: KobeU-001R000008722
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The percentage of neointimal coverage

  3 months

• The percentage of neointimal coverage

  6 months

Study Arms (1)

EES-XIENCE V

Groups who were treated with XIENCE V® everolimus eluting stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• left main artery
• severe calcification
• stent restenosis

Sponsors & Collaborators

• Kobe University: lead

Study Sites (1)

Kobe University Graduate School of Medicine

Kobe, Hyōgo, Japan

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Toshiro Shinke

  Kobe University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 21, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2015
• Last Updated: September 9, 2013

Record last verified: 2013-09

Locations

JP (1)