Coronary Artery DiseaseNCT00366015
Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating Room
A study testing Robotic-assisted Coronary Surgical Revascularization and PCI- Drug Eluting Stents in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study will combine coronary stenting with minimally invasive robotic coronary bypass surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded coronary arteries. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Robotic-assisted Coronary Surgical Revascularization and PCI- Drug Eluting Stents
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2003to 31 Dec 2010
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with class A or B1 low risk coronary artery lesion as defined by TIMI
Who cannot join
- Contraindications to PCI which include:
- Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm
- Contraindications to Robotic Surgery which include:
- Buried LAD, Unable to tolerate single lung ventilation, Inability to undergo beating heart surgery, Previous surgery of the left chest cavity, Lack of intrathoracic work space, Patients requiring emergency surgery,
- The following patients are also excluded:
- Patients with coagulation disorders; inability to tolerate GIIb/III inhibitors, Patients with ventricular arrhythmias, Patients with severe non-cardiac conditions with poor prognosis, Patients with a BMI >40, Patients with an ejection fraction of <30%, Patients with chronic renal insufficiency and creatinine >200umol/L, Patients who are >85 years of age, Patients participating in any other investigational device or study drug, Patients who have had previous thoracic surgery, Patients who have a pre-op intra-aortic balloon pump, Patients who are not able to follow the protocol requirements, Patients undergoing concomitant surgery; CABG + Valve surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
The London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
About this study
Official title: Same Procedure Cardiac Hybrid Surgery in a Specialty Built OR-- A Pilot Study
This study will combine coronary stenting with minimally invasive robotic coronary bypass surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded coronary arteries. Two previously approved and commonly performed procedures used to treat coronary artery disease(coronary stenting and robotic bypass surgery) are being combined into a hybrid surgery in a specialty built operating room. Patients with low risk coronary lesions will undergo cardiac hybrid revascularization using stenting and LIMA to LAD robotic bypass concomitantly. Patients' postoperative bleeding rates, angiographs and complication free rates will be recorded.
Read the detailed description
Coronary artery disease (CAD) is the leading cause of death in the United States and becomes more common as the population ages (American Heart Association, 2003). The symptoms of CAD may not become perceptible until the condition has advanced to a severe and serious stage, which might explain the large mortality and morbidity rates associated with heart disease.
At this point there are many procedures available to treat CAD all of which aim to improve myocardial blood flow, stop angina, increase exercise ability and ultimately free patients from medications and improve their quality of life. Medications are used to reduce blood pressure and relieve strain on the heart. Cardiologists use angioplasty, which compresses plaque deposits, and stenting, in which a small wire mesh tube is inserted into the diseased artery to revascularize the heart muscle. On-pump coronary artery bypass grafting (CABG) redirects blood flow around clogged vessels of the heart and is commonly used by cardiac surgeons to treat CAD because it has been proven to yield the lowest restenosis rate of all revascularization techniques (Cisowski, 2002). CABG is an effective yet painful and traumatic intervention.
The desire to discover a less distressing approach to coronary artery revascularization has led to a fairly new cardiac hybrid procedure that involves stenting followed by a minimally invasive left internal mammary artery (LIMA) to left anterior descending artery (LAD) bypass graft (Amodeo, 2002). The hybrid procedure for revascularization carries a lower morbidity than does on-pump CABG and is also quickly gaining acceptance in the surgical community (de Canniere et al, 2001). The two procedures of hybrid revascularization are currently performed within 24 to 48 hours of each other with little collaboration between cardiac surgeons and cardiologist.
This study will asses the efficacy and safety of cardiac hybrid surgery that combines stenting and robotic LIMA to LAD grafting in the same procedure in a specialty built operating room. Long term use of the antiplatelet inhibitor, clopidogrel, to be taken by patients in this study, was proven to significantly reduce the risk of adverse ischemic events after percutaneous coronary interventions (Steinhubl, 2002). In addition, the application of Bivalirudin (Direct Thrombin Inhibitor) will be assessed in this integrated myocardial revascularization scenario. The many attractive aspects of robotic hybrid bypass include the avoidance of the procedural phases (arrested heart, blood transfusion, median sternotomy and cardiopulmonary bypass) of on-pump CABG. Robotic LIMA to LAD bypass and stenting in the same procedure will allow cardiac surgeons and cardiologists to work together to help patients obtain safe and effective coronary artery revascularization.
- Conditions
- Coronary Artery Disease
- Being tested
- Robotic-assisted Coronary Surgical Revascularization, PCI- Drug Eluting Stents
- Keywords
- Coronary Artery Disease, PCI, Drug eluting stents, Coronary Hybrid Revascularization, Robotic CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted Coronary Surgical RevascularizationProcedure or surgery
Robotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console
PCI- Drug Eluting StentsProcedure or surgery
Drug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & efficacy of integrated myocardial revascularization performed in a single stage
Measured: 5 years post end of study
Secondary outcomes (8)
One-year postoperative stenosis rate (Stenosis may be evaluated by the angiographic documentation of blood flow).
Measured: One year
Success rate is defined as a reduction in stenosis to < 50%.
Measured: One year
Myocardial infarction,
Measured: within 30 days of surgery
Death,
Measured: within 30 days of surgery and/or within primary hospitalization
Repeat revascularization at any time after the robotic hybrid revascularization (Repeat revascularization are those involving a previously treated lesionfollowing the initial hybrid procedure)
Measured: One year
In-hospital complications during or after surgery,
Measured: within initial hospitalization or within 30 days of discharge
Inability to revascularize with the use of both stenting and LIMA to LAD bypass,
Measured: within initial hospitalization
Inability to revascularize with the use of the da Vinci Surgical System
Measured: within initial hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study start29 Jul 2003
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canada Foundation for Innovation, Ontario Innovative Trust, Ontario Research and Development Challenge Fund
- Responsible party
- Sponsor
- Investigators
- Bob Kiaii, MD, FRCSC, Principal investigator, Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366015
- Sponsor's protocol ID
- R-04-158
- Other IDs
- 9874
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2006
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Merry AF, Raudkivi PJ, Middleton NG, McDougall JM, Nand P, Mills BP, Webber BJ, Frampton CM, White HD. Bivalirudin versus heparin and protamine in off-pump coronary artery bypass surgery. Ann Thorac Surg. 2004 Mar;77(3):925-31; discussion 931. doi: 10.1016/j.athoracsur.2003.09.061.
PubMed 14992900Koster A, Spiess B, Chew DP, Krabatsch T, Tambeur L, DeAnda A, Hetzer R, Kuppe H, Smedira NG, Lincoff AM. Effectiveness of bivalirudin as a replacement for heparin during cardiopulmonary bypass in patients undergoing coronary artery bypass grafting. Am J Cardiol. 2004 Feb 1;93(3):356-9. doi: 10.1016/j.amjcard.2003.10.021.
PubMed 14759391Vassiliades TA Jr, Douglas JS, Morris DC, Block PC, Ghazzal Z, Rab ST, Cates CU. Integrated coronary revascularization with drug-eluting stents: immediate and seven-month outcome. J Thorac Cardiovasc Surg. 2006 May;131(5):956-62. doi: 10.1016/j.jtcvs.2005.10.058. Epub 2006 Apr 27.
PubMed 16678575Katz MR, Van Praet F, de Canniere D, Murphy D, Siwek L, Seshadri-Kreaden U, Friedrich G, Bonatti J. Integrated coronary revascularization: percutaneous coronary intervention plus robotic totally endoscopic coronary artery bypass. Circulation. 2006 Jul 4;114(1 Suppl):I473-6. doi: 10.1161/CIRCULATIONAHA.105.001537.
PubMed 16820621Cisowski M, Morawski W, Drzewiecki J, Kruczak W, Toczek K, Bis J, Bochenek A. Integrated minimally invasive direct coronary artery bypass grafting and angioplasty for coronary artery revascularization. Eur J Cardiothorac Surg. 2002 Aug;22(2):261-5. doi: 10.1016/s1010-7940(02)00262-2.
PubMed 12142196Zenati M, Cohen HA, Griffith BP. Alternative approach to multivessel coronary disease with integrated coronary revascularization. J Thorac Cardiovasc Surg. 1999 Mar;117(3):439-44; discussion 444-6. doi: 10.1016/s0022-5223(99)70322-3.
PubMed 10047645Angelini GD, Wilde P, Salerno TA, Bosco G, Calafiore AM. Integrated left small thoracotomy and angioplasty for multivessel coronary artery revascularisation. Lancet. 1996 Mar 16;347(9003):757-8. doi: 10.1016/s0140-6736(96)90107-5. No abstract available.
PubMed 8602013Bonatti J, Schachner T, Bonaros N, Laufer G, Kolbitsch C, Margreiter J, Jonetzko P, Pachinger O, Friedrich G. Robotic totally endoscopic coronary artery bypass and catheter based coronary intervention in one operative session. Ann Thorac Surg. 2005 Jun;79(6):2138-41. doi: 10.1016/j.athoracsur.2003.12.074.
PubMed 15919329Bonatti J, Schachner T, Bonaros N, Jonetzko P, Ohlinger A, Lockinger A, Stalzer B, Eschertzhuber S, Friedrich G. Treatment of double vessel coronary artery disease by totally endoscopic bypass surgery and drug-eluting stent placement in one simultaneous hybrid session. Heart Surg Forum. 2005;8(4):E284-6. doi: 10.1532/HSF98.20051136.
PubMed 16112943Dogan S, Aybek T, Andressen E, Byhahn C, Mierdl S, Westphal K, Matheis G, Moritz A, Wimmer-Greinecker G. Totally endoscopic coronary artery bypass grafting on cardiopulmonary bypass with robotically enhanced telemanipulation: report of forty-five cases. J Thorac Cardiovasc Surg. 2002 Jun;123(6):1125-31. doi: 10.1067/mtc.2002.121305.
PubMed 12063459
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Procedure Cardiac Hybrid Surgery in a Specialty Built OR-- A Pilot Study
- ClinicalTrials.gov ID
- NCT00366015
- Acronym / sponsor ID
- R-04-158
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, PCI, Drug eluting stents, Coronary Hybrid Revascularization, Robotic CABG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canada Foundation for Innovation, Ontario Innovative Trust, Ontario Research and Development Challenge Fund
- Study start
- 29 Jul 2003 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 18 Aug 2006 (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.
This study will combine coronary stenting with minimally invasive robotic coronary bypass surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded coronary arteries. Two previously approved and commonly performed procedures used to treat coronary artery disease(coronary stenting and robotic bypass surgery) are being combined into a hybrid surgery in a specialty built operating room. Patients with low risk coronary lesions will undergo cardiac hybrid revascularization using stenting and LIMA to LAD robotic bypass concomitantly. Patients' postoperative bleeding rates, angiographs and complication free rates will be recorded.
Detailed description
Coronary artery disease (CAD) is the leading cause of death in the United States and becomes more common as the population ages (American Heart Association, 2003). The symptoms of CAD may not become perceptible until the condition has advanced to a severe and serious stage, which might explain the large mortality and morbidity rates associated with heart disease.
At this point there are many procedures available to treat CAD all of which aim to improve myocardial blood flow, stop angina, increase exercise ability and ultimately free patients from medications and improve their quality of life. Medications are used to reduce blood pressure and relieve strain on the heart. Cardiologists use angioplasty, which compresses plaque deposits, and stenting, in which a small wire mesh tube is inserted into the diseased artery to revascularize the heart muscle. On-pump coronary artery bypass grafting (CABG) redirects blood flow around clogged vessels of the heart and is commonly used by cardiac surgeons to treat CAD because it has been proven to yield the lowest restenosis rate of all revascularization techniques (Cisowski, 2002). CABG is an effective yet painful and traumatic intervention.
The desire to discover a less distressing approach to coronary artery revascularization has led to a fairly new cardiac hybrid procedure that involves stenting followed by a minimally invasive left internal mammary artery (LIMA) to left anterior descending artery (LAD) bypass graft (Amodeo, 2002). The hybrid procedure for revascularization carries a lower morbidity than does on-pump CABG and is also quickly gaining acceptance in the surgical community (de Canniere et al, 2001). The two procedures of hybrid revascularization are currently performed within 24 to 48 hours of each other with little collaboration between cardiac surgeons and cardiologist.
This study will asses the efficacy and safety of cardiac hybrid surgery that combines stenting and robotic LIMA to LAD grafting in the same procedure in a specialty built operating room. Long term use of the antiplatelet inhibitor, clopidogrel, to be taken by patients in this study, was proven to significantly reduce the risk of adverse ischemic events after percutaneous coronary interventions (Steinhubl, 2002). In addition, the application of Bivalirudin (Direct Thrombin Inhibitor) will be assessed in this integrated myocardial revascularization scenario. The many attractive aspects of robotic hybrid bypass include the avoidance of the procedural phases (arrested heart, blood transfusion, median sternotomy and cardiopulmonary bypass) of on-pump CABG. Robotic LIMA to LAD bypass and stenting in the same procedure will allow cardiac surgeons and cardiologists to work together to help patients obtain safe and effective coronary artery revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with class A or B1 low risk coronary artery lesion as defined by TIMI
Key exclusion criteria (6 listed)
- Contraindications to PCI which include:
- Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm
- Contraindications to Robotic Surgery which include:
- Buried LAD, Unable to tolerate single lung ventilation, Inability to undergo beating heart surgery, Previous surgery of the left chest cavity, Lack of intrathoracic work space, Patients requiring emergency surgery,
- Patients with coagulation disorders; inability to tolerate GIIb/III inhibitors, Patients with ventricular arrhythmias, Patients with severe non-cardiac conditions with poor prognosis, Patients with a BMI >40, Patients with an ejection fraction of <30%, Patients with chronic renal insufficiency and creatinine >200umol/L, Patients who are >85 years of age, Patients participating in any other investigational device or study drug, Patients who have had previous thoracic surgery, Patients who have a pre-op intra-aortic balloon pump, Patients who are not able to follow the protocol requirements, Patients undergoing concomitant surgery; CABG + Valve surgery
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 |
|---|---|---|
| Robotic-assisted Coronary Surgical RevascularizationRobotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console | Procedure or surgery | – |
| PCI- Drug Eluting StentsDrug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery | Procedure or surgery | – |
Primary outcome
Safety & efficacy of integrated myocardial revascularization performed in a single stage
Time frame: 5 years post end of study
8 secondary outcomes
One-year postoperative stenosis rate (Stenosis may be evaluated by the angiographic documentation of blood flow).
Time frame: One year
Success rate is defined as a reduction in stenosis to < 50%.
Time frame: One year
Myocardial infarction,
Time frame: within 30 days of surgery
Death,
Time frame: within 30 days of surgery and/or within primary hospitalization
Repeat revascularization at any time after the robotic hybrid revascularization (Repeat revascularization are those involving a previously treated lesionfollowing the initial hybrid procedure)
Time frame: One year
In-hospital complications during or after surgery,
Time frame: within initial hospitalization or within 30 days of discharge
Inability to revascularize with the use of both stenting and LIMA to LAD bypass,
Time frame: within initial hospitalization
Inability to revascularize with the use of the da Vinci Surgical System
Time frame: within initial hospitalization
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 28 Aug 2017.
- Background: PubMed 14992900Merry AF, Raudkivi PJ, Middleton NG, McDougall JM, Nand P, Mills BP, Webber BJ, Frampton CM, White HD. Bivalirudin versus heparin and protamine in off-pump coronary artery bypass surgery. Ann Thorac Surg. 2004 Mar;77(3):925-31; discussion 931. doi: 10.1016/j.athoracsur.2003.09.061.
- Background: PubMed 14759391Koster A, Spiess B, Chew DP, Krabatsch T, Tambeur L, DeAnda A, Hetzer R, Kuppe H, Smedira NG, Lincoff AM. Effectiveness of bivalirudin as a replacement for heparin during cardiopulmonary bypass in patients undergoing coronary artery bypass grafting. Am J Cardiol. 2004 Feb 1;93(3):356-9. doi: 10.1016/j.amjcard.2003.10.021.
- Background: PubMed 16678575Vassiliades TA Jr, Douglas JS, Morris DC, Block PC, Ghazzal Z, Rab ST, Cates CU. Integrated coronary revascularization with drug-eluting stents: immediate and seven-month outcome. J Thorac Cardiovasc Surg. 2006 May;131(5):956-62. doi: 10.1016/j.jtcvs.2005.10.058. Epub 2006 Apr 27.
- Background: PubMed 16820621Katz MR, Van Praet F, de Canniere D, Murphy D, Siwek L, Seshadri-Kreaden U, Friedrich G, Bonatti J. Integrated coronary revascularization: percutaneous coronary intervention plus robotic totally endoscopic coronary artery bypass. Circulation. 2006 Jul 4;114(1 Suppl):I473-6. doi: 10.1161/CIRCULATIONAHA.105.001537.
- Background: PubMed 12142196Cisowski M, Morawski W, Drzewiecki J, Kruczak W, Toczek K, Bis J, Bochenek A. Integrated minimally invasive direct coronary artery bypass grafting and angioplasty for coronary artery revascularization. Eur J Cardiothorac Surg. 2002 Aug;22(2):261-5. doi: 10.1016/s1010-7940(02)00262-2.
- Background: PubMed 10047645Zenati M, Cohen HA, Griffith BP. Alternative approach to multivessel coronary disease with integrated coronary revascularization. J Thorac Cardiovasc Surg. 1999 Mar;117(3):439-44; discussion 444-6. doi: 10.1016/s0022-5223(99)70322-3.
- Background: PubMed 8602013Angelini GD, Wilde P, Salerno TA, Bosco G, Calafiore AM. Integrated left small thoracotomy and angioplasty for multivessel coronary artery revascularisation. Lancet. 1996 Mar 16;347(9003):757-8. doi: 10.1016/s0140-6736(96)90107-5. No abstract available.
- Background: PubMed 15919329Bonatti J, Schachner T, Bonaros N, Laufer G, Kolbitsch C, Margreiter J, Jonetzko P, Pachinger O, Friedrich G. Robotic totally endoscopic coronary artery bypass and catheter based coronary intervention in one operative session. Ann Thorac Surg. 2005 Jun;79(6):2138-41. doi: 10.1016/j.athoracsur.2003.12.074.
- Background: PubMed 16112943Bonatti J, Schachner T, Bonaros N, Jonetzko P, Ohlinger A, Lockinger A, Stalzer B, Eschertzhuber S, Friedrich G. Treatment of double vessel coronary artery disease by totally endoscopic bypass surgery and drug-eluting stent placement in one simultaneous hybrid session. Heart Surg Forum. 2005;8(4):E284-6. doi: 10.1532/HSF98.20051136.
- Background: PubMed 12063459Dogan S, Aybek T, Andressen E, Byhahn C, Mierdl S, Westphal K, Matheis G, Moritz A, Wimmer-Greinecker G. Totally endoscopic coronary artery bypass grafting on cardiopulmonary bypass with robotically enhanced telemanipulation: report of forty-five cases. J Thorac Cardiovasc Surg. 2002 Jun;123(6):1125-31. doi: 10.1067/mtc.2002.121305.
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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.
Bob Kiaii, MD, FRCSC principal investigator
Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted Coronary Surgical Revascularization and PCI- Drug Eluting Stents in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 6 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 28 Aug 2017. 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 Canada. 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?
Safety & efficacy of integrated myocardial revascularization performed in a single stage (time frame: 5 years post end of study). 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 NCT00366015, which also lists 10 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 28 Aug 2017.