NCT02263313

Brief Summary

In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

Same day

First QC Date

September 23, 2014

Last Update Submit

October 7, 2014

Conditions

Coronary Restenosis

Keywords

Safety and efficacyCombo stentLate loss thrombosisLate loss catch up

Outcome Measures

Primary Outcomes (1)

  • Composite Major Adverse Cardiac Events (MACE)

    beyond 36 months

Secondary Outcomes (6)

  • All-cause mortality

    beyond 36 months

  • Myocardial infarction

    beyond 36 months

  • Target Lesion Revascularization

    beyond 36 months

  • Angina Class

    beyond 36 months

  • Target Vessel Failure

    beyond 36 months

  • +1 more secondary outcomes

Study Arms (1)

EGO-COMBO group

Previously enrolled into EGO-COMBO Pilot study and with combo stent

Other: EGO-COMBO group

Interventions

EGO-COMBO groupOTHER

Assess the safety and effectiveness of Combo stent

EGO-COMBO group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a single centre observational study to assess the safety and effectiveness clinical endpoints of COMBO TM stent beyond 36 months. Clinical notes for all subjects that previously participated in EGO-COMBO Pilot Study (UW 10-342) will be reviewed for clinical end points according to the definition of Academic Research Consortium and angina symptoms will be classified with Canadian Cardiovascular Society Angina Classification.

You may qualify if:

  • Patient previously participated in EGO-COMBO Pilot Study (UW 10-342)

You may not qualify if:

  • Patient not previously participated in EGO-COMBO Pilot Study (UW 10-342)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong, China

Location

Related Publications (8)

  • 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

  • Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013 Apr;6(4):334-43. doi: 10.1016/j.jcin.2012.10.018. Epub 2013 Mar 20.

    PMID: 23523459RESULT

  • 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

  • Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010 Jun 1;3(3):257-66. doi: 10.1161/CIRCINTERVENTIONS.109.919936. Epub 2010 May 4.

    PMID: 20442358RESULT

  • 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

  • Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

    PMID: 17470709RESULT

  • 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

  • Lee SW, Lam SC, Tam FC, Chan KK, Shea CP, Kong SL, Wong AY, Yung A, Zhang LW, Tse HF, Wu KK, Chan R, Haude M, Mehran R, Mintz GS, Maehara A. Evaluation of Early Healing Profile and Neointimal Transformation Over 24 Months Using Longitudinal Sequential Optical Coherence Tomography Assessments and 3-Year Clinical Results of the New Dual-Therapy Endothelial Progenitor Cell Capturing Sirolimus-Eluting Combo Stent: The EGO-Combo Study. Circ Cardiovasc Interv. 2016 Jul;9(7):e003469. doi: 10.1161/CIRCINTERVENTIONS.115.003469.

    PMID: 27418609DERIVED

Related Links

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Wai Luen Stephen LEE, MD

    The Univeristy of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief

Study Record Dates

First Submitted

September 23, 2014

First Posted

October 13, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

CN(1)