NCT01272895

Brief Summary

All patients who have received GENOUS stent implantation at Queen Mary Hospital for treatment of ischemic heart disease are eligible for this study. Those with clinical indications to undergo restudy coronary angiogram or staged procedure PCI will be primarily recruited into this study. Optical coherence tomography (OCT) will be performed early after stent implantation to evaluate vascular healing response and neointimal coverage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

December 28, 2010

Last Update Submit

February 27, 2013

Conditions

Coronary Artery Disease

Keywords

OCT imagesStent strut coverageEndothelializationNeointimal thickness, area and hyperplasiaStent malapposition

Outcome Measures

Primary Outcomes (1)

  • Percentage stent coverage by OCT in early phases.

    Percentage stent strut coverage at weekly intervals from 2nd to 6th week after EPC capturing stent implantation as assessed by OCT according to our OCT Early Coverage Classification.

    At 2nd, 3rd, 4th, 5th, and 6th weeks after stent implantation

Secondary Outcomes (1)

  • Other OCT Findings

    At 2nd, 3rd, 4th, 5th, and 6th week

Study Arms (1)

GENOUS stent

EXPERIMENTAL
Device: Coronary Intervention (GENOUS stent)

Interventions

Coronary Intervention (GENOUS stent)DEVICE

GENOUS stent (Coronary Intervention)

Also known as: EPC capturing Genous R-Stent
GENOUS stent

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-85 years old who received GENOUS stent treatment for ischemic coronary disease, and
  • Clinically indicated for a follow-up coronary angiogram or repeated (staged) coronary interventions within 3 months.

You may not qualify if:

  • Patients who refuse to consent to coronary angiogram or coronary angioplasty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (5)

  • Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048.

    PMID: 15893169RESULT

  • Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-term clinical follow-up. Am Heart J. 2008 Jan;155(1):128-32. doi: 10.1016/j.ahj.2007.08.031. Epub 2007 Nov 26.

    PMID: 18082503RESULT

  • Miglionico M, Patti G, D'Ambrosio A, Di Sciascio G. Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: a prospective single-center registry in high-risk patients. Catheter Cardiovasc Interv. 2008 Apr 1;71(5):600-4. doi: 10.1002/ccd.21437.

    PMID: 18360849RESULT

  • Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.

    PMID: 18307999RESULT

  • Prati F, Cera M, Ramazzotti V, Imola F, Giudice R, Albertucci M. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroIntervention. 2007 Nov;3(3):365-70. doi: 10.4244/eijv3i3a66.

    PMID: 19737719RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseHyperplasia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen WL Lee, MD FRCP FACC

    Queen Mary Hospital, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Chief

Study Record Dates

First Submitted

December 28, 2010

First Posted

January 10, 2011

Study Start

June 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

HK(1)