Coronary DiseaseNCT01756807
EGO-COMBO Angiographic Extension Study
A study testing The COMBO Stent in people with Coronary Disease, run by Prof. Stephen Lee at 1 site in China.
Trial summary
Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent angiographic extension Study (EGO-COMBO angiographic extension Study) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- The COMBO Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jun 2013
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18-85 years old
- Patient who agrees to have follow-up coronary angiograms
- Patient who were previously enrolled in EGO-COMBO study
Who cannot join
- Patient who refuses to consent to coronary angiogram or coronary angioplasty
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority
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 Angiographic Extension Study (EGO-COMBO Angiographic Extension Study)
Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent angiographic extension Study (EGO-COMBO angiographic extension Study)
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 has been implanted in 60 patients at Queen Mary Hospital. All patients have remained in good condition since the treatment.
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 developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall 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 have been investigated in the previous REMEDEE Study.
Animal study has shown the COMBO Stent promotes endothelialization and reduces neointima formation, as assessed by both optical coherence tomography (OCT) and histopathology (5). Even though COMBO Stents have been used and found to be safe in over 210 patients world-wide and in about 61 patients at Queen Mary Hospital under the EGO-COMBO Study Protocol, such beneficial endothelial coverage as assessed by OCT has never been documented in human subjects.
This current EGO-COMBO angiographic extension study protocol is designed based on the approved protocol EGO-COMBO Study (IRB: UW 10-342). This current study mainly focuses on the time frame, degree of endothelialization, and the subsequent neointimal proliferation after COMBO Stent implantation from 2 years, as assessed by intracoronary optical coherence tomography (OCT).
Intracoronary optical coherence tomography (OCT) is a simple catheter-based imaging technique using optic fibre to achieve very detailed assessment (resolution down to 100 microns) in intra-coronary stent apposition, early stent coverage (endothelialization) and late stent neoinitmal growth (restenosis). It is performed as part of routine cardiac catheterization procedure and provides high-resolution cross sectional images of the coronary arteries. OCT has been shown to be safe in clinical practice (6, 7). The C7XR OCT system (Frequency Domain OCT) is a commercial available product with CE Mark and FDA approval. The OCT catheter is just a non-occlusive optic fibre which is extremely small and flexible and will pose no additional risk to the patient other than those inherent risks of a standard angioplasty procedure.
- Conditions
- Coronary Disease
- Being tested
- The COMBO Stent
- Keywords
- Optical Coherence Tomography, Geneous Stent, Combo Stent
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The COMBO StentDevice
The COMBO Stent is developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall 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 have been investigated in the previous REMEDEE Study.
| Study group | Role | What they receive |
|---|---|---|
| The Combo Stent | Experimental | The COMBO Stent is developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall 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 have been investigated in the previous REMEDEE Study. Receives: Device: The COMBO Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary end-points of OCT findings on coverage (degree of endothelialization) and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area), binary restenosis and late angiographic late loss by QCA at two years restudy.
Co-primary end-points of OCT findings on coverage (degree of endothelialization) and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area), binary restenosis and late angiographic late loss by QCA at two years restudy.
Measured: At the two year restudy date
Secondary outcomes (1)
Any major adverse cardiac events at two years restudy.
Any major adverse cardiac events at two years restudy.
Measured: At the two year restudy date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Stephen Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Stephen Lee, The University of Hong Kong
- Investigators
- Stephen WL Lee, MD FRCP FACC, Principal investigator, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756807
- Sponsor's protocol ID
- UW 12-472 (IRB HK)
- Status last verified
- Oct 2014
- First submitted
- 20 Dec 2012
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alfonso F, Dutary J, Paulo M, Gonzalo N, Perez-Vizcayno MJ, Jimenez-Quevedo P, Escaned J, Banuelos C, Hernandez R, Macaya C. Combined use of optical coherence tomography and intravascular ultrasound imaging in patients undergoing coronary interventions for stent thrombosis. Heart. 2012 Aug;98(16):1213-20. doi: 10.1136/heartjnl-2012-302183.
PubMed 22826559Kutryk MJ, Kuliszewski MA. In vivo endothelial progenitor cell seeding for the accelerated endothelialization of endovascular devices. Am J Cardiol 2003; 92:94L
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.
PubMed 15893169Co 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 18082503Miglionico 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.
PubMed 18360849Granada 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 20442358Yamaguchi 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 18307999Prati 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 19737719Lee 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 23 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 Angiographic Extension Study (EGO-COMBO Angiographic Extension Study)
- ClinicalTrials.gov ID
- NCT01756807
- Acronym / sponsor ID
- UW 12-472 (IRB HK)
- Conditions
- Coronary Disease
- Keywords
- Optical Coherence Tomography, Geneous Stent, Combo Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Prof. Stephen LeeUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Dec 2012 (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.
Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent angiographic extension Study (EGO-COMBO angiographic extension Study)
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 has been implanted in 60 patients at Queen Mary Hospital. All patients have remained in good condition since the treatment.
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 developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall 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 have been investigated in the previous REMEDEE Study.
Animal study has shown the COMBO Stent promotes endothelialization and reduces neointima formation, as assessed by both optical coherence tomography (OCT) and histopathology (5). Even though COMBO Stents have been used and found to be safe in over 210 patients world-wide and in about 61 patients at Queen Mary Hospital under the EGO-COMBO Study Protocol, such beneficial endothelial coverage as assessed by OCT has never been documented in human subjects.
This current EGO-COMBO angiographic extension study protocol is designed based on the approved protocol EGO-COMBO Study (IRB: UW 10-342). This current study mainly focuses on the time frame, degree of endothelialization, and the subsequent neointimal proliferation after COMBO Stent implantation from 2 years, as assessed by intracoronary optical coherence tomography (OCT).
Intracoronary optical coherence tomography (OCT) is a simple catheter-based imaging technique using optic fibre to achieve very detailed assessment (resolution down to 100 microns) in intra-coronary stent apposition, early stent coverage (endothelialization) and late stent neoinitmal growth (restenosis). It is performed as part of routine cardiac catheterization procedure and provides high-resolution cross sectional images of the coronary arteries. OCT has been shown to be safe in clinical practice (6, 7). The C7XR OCT system (Frequency Domain OCT) is a commercial available product with CE Mark and FDA approval. The OCT catheter is just a non-occlusive optic fibre which is extremely small and flexible and will pose no additional risk to the patient other than those inherent risks of a standard angioplasty procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Combo Stent | Experimental | Device: The COMBO StentThe COMBO Stent is developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall 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 have been investigated in the previous REMEDEE Study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18-85 years old
- Patient who agrees to have follow-up coronary angiograms
- Patient who were previously enrolled in EGO-COMBO study
Key exclusion criteria (1 listed)
- Patient who refuses to consent to coronary angiogram or coronary angioplasty
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 |
|---|---|---|
| The COMBO StentThe COMBO Stent is developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall 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 have been investigated in the previous REMEDEE Study. | Device | The Combo Stent |
Primary outcome
Co-primary end-points of OCT findings on coverage (degree of endothelialization) and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area), binary restenosis and late angiographic late loss by QCA at two years restudy.
Time frame: At the two year restudy date
Co-primary end-points of OCT findings on coverage (degree of endothelialization) and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area), binary restenosis and late angiographic late loss by QCA at two years restudy.
1 secondary outcome
Any major adverse cardiac events at two years restudy.
Time frame: At the two year restudy date.
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 23 Oct 2014.
- Background: PubMed 22826559Alfonso F, Dutary J, Paulo M, Gonzalo N, Perez-Vizcayno MJ, Jimenez-Quevedo P, Escaned J, Banuelos C, Hernandez R, Macaya C. Combined use of optical coherence tomography and intravascular ultrasound imaging in patients undergoing coronary interventions for stent thrombosis. Heart. 2012 Aug;98(16):1213-20. doi: 10.1136/heartjnl-2012-302183.
- BackgroundKutryk MJ, Kuliszewski MA. In vivo endothelial progenitor cell seeding for the accelerated endothelialization of endovascular devices. Am J Cardiol 2003; 92:94L
- Background: 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.
- Background: 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.
- Background: PubMed 18360849Miglionico 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.
- Background: 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.
- Background: 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.
- Background: 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.
- 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.
Related trials for Coronary Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
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.
Stephen WL Lee, MD FRCP FACC principal investigator
Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The COMBO Stent in people with Coronary Disease, run by Prof. Stephen Lee 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 3 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 23 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?
Co-primary end-points of OCT findings on coverage (degree of endothelialization) and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area), binary restenosis and late angiographic late loss by QCA at two years restudy. (time frame: At the two year restudy date). 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 NCT01756807, which also lists 9 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 23 Oct 2014.