Coronary RestenosisNCT02263313
EGO-COMBO Clinical End-point Extension Study Beyond 36 Months
An observational study of Coronary Restenosis, run by The University of Hong Kong at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Restenosis
- What is being tested?
- EGO-COMBO group
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient previously participated in EGO-COMBO Pilot Study (UW 10-342)
Who cannot join
- Patient not previously participated in EGO-COMBO Pilot Study (UW 10-342)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medicine, Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
About this study
Official title: Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent 36-months Clinical End-point Extension Study (EGO-COMBO Clinical End-point Extension Study Beyond 36 Months)
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).
Read the detailed description
The Genous Stent (the EPC Capture R-stent, OrbusNeich Medical Inc., Fort Lauderdale, FL) is commercially available and has been used extensively in standard coronary intervention in the treatment of more than 200 patients with critical coronary stenoses at Queen Mary Hospital. The COMBO Stent (OrbusNeich Medical Inc., Fort Lauderdale, FL) is an improved version of the Genous Stent and is now widely available for clinical use in all Hong Kong hospitals. To date, more than 300 patients in Queen Mary Hospital have received the COMBO stent as treatment for their coronary artery disease, and all of them remained stable clinically.
The Genous Stent is a bio-engineered 316L stainless steel coronary stent with a biocompatible coating having specific CD34 antibody on the inner surface. CD34 is a surface antigen present on circulating endothelial progenitor cell (EPC). It will be bonded to the CD34 antibody, resulting in capturing of the EPC onto the stent surface and differentiation into endothelial layer. Animal model has demonstrated that a functional endothelial layer could be formed as soon as 24 to 48 hours after Genous stent implantation (1). The HEALING-FIM registry has shown that Genous stent is clinically safe and effective in the treatment of coronary stenosis (2). Recent reports have further confirmed its efficacy in patients with acute coronary syndrome requiring urgent revascularization (3,4).
The COMBO Stent is an improved version of the Genous Stent. The stent delivers a drug called sirolimus to the treated coronary blood vessel. This stent also incorporates a CD34 antibody coating that is designed to promote the healing of the treated coronary artery by catching endothelial progenitor cells from circulating blood as they pass through the stent. These cells are pro-healing and will help the blood vessel wall to heal over the stent more quickly and restore normal tissue function in the stented area. The combination of these two technologies in this new Combo stent is expected to produce even better clinical results, which are published in the REMEDEE Study.
Pre-clinical animal study has already shown the Combo Stent promoted endothelialization and reduced neointima formation, as assessed by both optical coherence tomography (OCT) and histopathology (5). However, such beneficial endothelial coverage as assessed by OCT has never been documented in human subjects, and has been addressed by previous study protocol: the EGO Study (IRB: UW 10-256), EGO-COMBO Pilot Study (UW 10-342) and EGO-COMBO angiographic extension study (UW 12-472). Queen Mary Hospital is currently the single cardiac centre worldwide with such vast experience in using the COMBO stent for percutaneous coronary intervention, together with intracoronary OCT to profile the stent's healing progress and subsequent neo-intimal growth and behaviour.
This current study protocol serves as an extension study to evaluate the long term clinical safety and efficacy of COMBO stent beyond 36 months post-implantation.
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.
- Conditions
- Coronary Restenosis
- Being tested
- EGO-COMBO group
- Keywords
- Safety and efficacy, Combo stent, Late loss thrombosis, Late loss catch up
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGO-COMBO groupOther
Assess the safety and effectiveness of Combo stent
| Study group | Role | What they receive |
|---|---|---|
| EGO-COMBO group | Previously enrolled into EGO-COMBO Pilot study and with combo stent Receives: Other: EGO-COMBO group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Major Adverse Cardiac Events (MACE)
Measured: beyond 36 months
Secondary outcomes (6)
All-cause mortality
Measured: beyond 36 months
Myocardial infarction
Measured: beyond 36 months
Target Lesion Revascularization
Measured: beyond 36 months
Angina Class
Measured: beyond 36 months
Target Vessel Failure
Measured: beyond 36 months
Cardiac Death
Measured: beyond 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary RestenosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Stephen Lee, The University of Hong Kong
- Investigators
- Wai Luen Stephen LEE, MD, Principal investigator, The Univeristy of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263313
- Sponsor's protocol ID
- UW 14-456 (IRB HKU)
- Status last verified
- Oct 2014
- First submitted
- 23 Sep 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19737719Haude 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.
PubMed 23523459Yamaguchi 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.
PubMed 18307999Granada 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.
PubMed 20442358Co 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.
PubMed 18082503Cutlip 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.
PubMed 17470709Aoki 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.
PubMed 15893169Lee 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.
PubMed 27418609
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent 36-months Clinical End-point Extension Study (EGO-COMBO Clinical End-point Extension Study Beyond 36 Months)
- ClinicalTrials.gov ID
- NCT02263313
- Acronym / sponsor ID
- UW 14-456 (IRB HKU)
- Conditions
- Coronary Restenosis
- Keywords
- Safety and efficacy, Combo stent, Late loss thrombosis, Late loss catch up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The Genous Stent (the EPC Capture R-stent, OrbusNeich Medical Inc., Fort Lauderdale, FL) is commercially available and has been used extensively in standard coronary intervention in the treatment of more than 200 patients with critical coronary stenoses at Queen Mary Hospital. The COMBO Stent (OrbusNeich Medical Inc., Fort Lauderdale, FL) is an improved version of the Genous Stent and is now widely available for clinical use in all Hong Kong hospitals. To date, more than 300 patients in Queen Mary Hospital have received the COMBO stent as treatment for their coronary artery disease, and all of them remained stable clinically.
The Genous Stent is a bio-engineered 316L stainless steel coronary stent with a biocompatible coating having specific CD34 antibody on the inner surface. CD34 is a surface antigen present on circulating endothelial progenitor cell (EPC). It will be bonded to the CD34 antibody, resulting in capturing of the EPC onto the stent surface and differentiation into endothelial layer. Animal model has demonstrated that a functional endothelial layer could be formed as soon as 24 to 48 hours after Genous stent implantation (1). The HEALING-FIM registry has shown that Genous stent is clinically safe and effective in the treatment of coronary stenosis (2). Recent reports have further confirmed its efficacy in patients with acute coronary syndrome requiring urgent revascularization (3,4).
The COMBO Stent is an improved version of the Genous Stent. The stent delivers a drug called sirolimus to the treated coronary blood vessel. This stent also incorporates a CD34 antibody coating that is designed to promote the healing of the treated coronary artery by catching endothelial progenitor cells from circulating blood as they pass through the stent. These cells are pro-healing and will help the blood vessel wall to heal over the stent more quickly and restore normal tissue function in the stented area. The combination of these two technologies in this new Combo stent is expected to produce even better clinical results, which are published in the REMEDEE Study.
Pre-clinical animal study has already shown the Combo Stent promoted endothelialization and reduced neointima formation, as assessed by both optical coherence tomography (OCT) and histopathology (5). However, such beneficial endothelial coverage as assessed by OCT has never been documented in human subjects, and has been addressed by previous study protocol: the EGO Study (IRB: UW 10-256), EGO-COMBO Pilot Study (UW 10-342) and EGO-COMBO angiographic extension study (UW 12-472). Queen Mary Hospital is currently the single cardiac centre worldwide with such vast experience in using the COMBO stent for percutaneous coronary intervention, together with intracoronary OCT to profile the stent's healing progress and subsequent neo-intimal growth and behaviour.
This current study protocol serves as an extension study to evaluate the long term clinical safety and efficacy of COMBO stent beyond 36 months post-implantation.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGO-COMBO group | – | Other: EGO-COMBO groupPreviously enrolled into EGO-COMBO Pilot study and with combo stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patient previously participated in EGO-COMBO Pilot Study (UW 10-342)
Key exclusion criteria (1 listed)
- Patient not previously participated in EGO-COMBO Pilot Study (UW 10-342)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGO-COMBO groupAssess the safety and effectiveness of Combo stent | Other | EGO-COMBO group |
Primary outcome
Composite Major Adverse Cardiac Events (MACE)
Time frame: beyond 36 months
6 secondary outcomes
All-cause mortality
Time frame: beyond 36 months
Myocardial infarction
Time frame: beyond 36 months
Target Lesion Revascularization
Time frame: beyond 36 months
Angina Class
Time frame: beyond 36 months
Target Vessel Failure
Time frame: beyond 36 months
Cardiac Death
Time frame: beyond 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Results publication: PubMed 19737719Prati 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.
- Results publication: PubMed 23523459Haude 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.
- Results publication: PubMed 18307999Yamaguchi 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.
- Results publication: PubMed 20442358Granada 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.
- Results publication: PubMed 18082503Co 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.
- Results publication: PubMed 17470709Cutlip 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.
- Results publication: PubMed 15893169Aoki 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.
- Derived from this study: PubMed 27418609Lee 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.
- . Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: A prospective single-centre registry in high-risk patients. Cath and Cardiovascular Interventions 2008; 71:600-604Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Luen Stephen LEE, MD principal investigator
The Univeristy of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Restenosis, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Major Adverse Cardiac Events (MACE) (time frame: beyond 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263313, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.