Coronary Artery DiseaseNCT01034371
Comparison of One-stop Hybrid Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Disease
A study testing Minimally invasive direct coronary artery bypass, PCI-Drug eluting stents and Off-pump coronary artery bypass in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 2 sites in China.
Trial summary
The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Minimally invasive direct coronary artery bypass, PCI-Drug eluting stents and Off-pump coronary artery bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2009to Dec 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory);
- LAD diseases not suitable for PCI [i.e. chronic totally occlusion (CTO), severe calcification or/and angulated lesions, bifurcation or trifurcation lesions];
- Angiographic characteristics of non-LAD lesion(s) amiable to PCI;
- Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
- Evaluated by both cardiac surgeon and cardiologist together.
Who cannot join
- Need for emergent CABG;
- Prior CABG;
- Prior PCI with stenting within 6 months of study entry;
- Stroke with 6 months of study entry;
- Overt congestive heart failure;
- Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery);
Show all 12Show fewer
- Hemodynamic instability;
- Situations in which complete revascularization is not possible served;
- Allergy to radiographic contrast, aspirin or clopidogrel.
- Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine;
- Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
- History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
Beijing, Beijing Municipality, 100037
Shengshou Hu, M.D., 0086-010-8839-8359, shengshouhu@yahoo.com
Zhe Zheng, M.D., 0086-010-8839-8359, zhengzhefuwai@tom.com
- Recruiting
Institute of cardiovascular diseases & Fuwai hospital
Beijing, Beijing Municipality, 100037
Shengshou Hu, M.D., 0086-10-8839-8359, shengshouhu@yahoo.com
Zhe Zheng, M.D., 0086-10-8839-8359, zhengzhefuwai@tom.com
About this study
Official title: Comparison of "One-stop" Hybrid Coronary Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Coronary Artery Disease
The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with off-pump coronary artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.
Read the detailed description
- With the development of specialized devices and experience, off-pump coronary artery bypass (OPCAB) has been a well-established less invasive technique for coronary revascularization. Compared with conventional on-pump coronary artery bypass grafting (CABG), OPCAB avoids the use of cardiopulmonary bypass and cardioplegic arrest, and is associated with decreased morbidity, shorter length of stay in ICU and hospital, and less perioperative complications, especially in elderly patients with severe comorbidities. "One-stop" (also named simultaneous) hybrid coronary revascularization is also a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). It allows surgical and interventional procedures to be performed consecutively in the "one-stop" hybrid operating suite, an enhanced operating room equipped with radiographic capability, wherein the left intramammary artery (LIMA) is placed on the left anterior descending artery (LAD) by minimally invasive procedure, immediately followed by percutaneous coronary intervention/stenting on the non-LAD lesions. However, few studies are now available on the outcomes of coronary revascularization between the new hybrid strategy with conventional OPCAB. This study is a single center randomized clinical trial to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with OPCAB in selected patients with multivessel CAD with suitable coronary anatomy.
Sample size:
- We examined the results of SYNTAX trial and of our institution published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 13% for OPCAB. The sample calculated for this trial is 400 patients.
Design/Methodology:
- Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional OPCAB in 400 patients with suitable anatomy who need revascularization.
Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional OPCAB.
- Randomization: Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB. An expertise-based randomization will be used.
The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study.
Study intervention:
- Candidates will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB.
- Conditions
- Coronary Artery Disease
- Being tested
- Minimally invasive direct coronary artery bypass, PCI-Drug eluting stents, Off-pump coronary artery bypass
- Keywords
- Coronary Artery Disease; Hybrid Revascularization;, Percutaneous Coronary Intervention; Coronary Artery Bypass
- 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.
Minimally invasive direct coronary artery bypassProcedure or surgery
Also called MIDCAB
MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
PCI-Drug eluting stentsProcedure or surgery
Also called PCI
PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB.
Device: Polymer-based Sirolimus-Eluting Stents (SES).
Off-pump coronary artery bypassProcedure or surgery
Also called OPCAB
Procedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
| Study group | Role | What they receive |
|---|---|---|
| One-stop hybrid revasularization | Experimental | Not described Receives: Procedure: Minimally invasive direct coronary artery bypass; Procedure: PCI-Drug eluting stents |
| Off-pump coronary artery bypass | Active comparator | Not described Receives: Procedure: Off-pump coronary artery bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
Measured: 1 year
Secondary outcomes (8)
Overall MACCE rate.
Measured: 30 days after procedure and 2 years after enrollment
Cardiac death.
Measured: 30 days after procedure, 1 and 2 years after enrollment
Documented myocardial infarction.
Measured: 30 days after procedure, 1 and 2 years after enrollment
Target lesion revascularization.
Measured: 30 days after procedure, 1 and 2 years after enrollment
Recurrence of Angina.
Measured: 1 and 2 years after enrollment
Cost-effectiveness analysis.
Measured: 1 and 2 years after enrollment
Quality of life.
Measured: 6 months, 1 and 2 years after enrollment
Rehospitalization.
Measured: 6 months, 1 and 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Investigators
- Shengshou Hu, M.D., Study director, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034371
- Sponsor's protocol ID
- 20091216
- Status last verified
- Dec 2009
- First submitted
- 16 Dec 2009
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of "One-stop" Hybrid Coronary Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01034371
- Acronym / sponsor ID
- 20091216
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease; Hybrid Revascularization;, Percutaneous Coronary Intervention; Coronary Artery Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (estimated)
- First posted
- 17 Dec 2009 (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.
The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with off-pump coronary artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.
Detailed description
- With the development of specialized devices and experience, off-pump coronary artery bypass (OPCAB) has been a well-established less invasive technique for coronary revascularization. Compared with conventional on-pump coronary artery bypass grafting (CABG), OPCAB avoids the use of cardiopulmonary bypass and cardioplegic arrest, and is associated with decreased morbidity, shorter length of stay in ICU and hospital, and less perioperative complications, especially in elderly patients with severe comorbidities. "One-stop" (also named simultaneous) hybrid coronary revascularization is also a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). It allows surgical and interventional procedures to be performed consecutively in the "one-stop" hybrid operating suite, an enhanced operating room equipped with radiographic capability, wherein the left intramammary artery (LIMA) is placed on the left anterior descending artery (LAD) by minimally invasive procedure, immediately followed by percutaneous coronary intervention/stenting on the non-LAD lesions. However, few studies are now available on the outcomes of coronary revascularization between the new hybrid strategy with conventional OPCAB. This study is a single center randomized clinical trial to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with OPCAB in selected patients with multivessel CAD with suitable coronary anatomy.
Sample size:
- We examined the results of SYNTAX trial and of our institution published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 13% for OPCAB. The sample calculated for this trial is 400 patients.
Design/Methodology:
- Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional OPCAB in 400 patients with suitable anatomy who need revascularization.
Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional OPCAB.
- Randomization: Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB. An expertise-based randomization will be used.
The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study.
Study intervention:
- Candidates will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-stop hybrid revasularization | Experimental | Procedure: Minimally invasive direct coronary artery bypass, Procedure: PCI-Drug eluting stents |
| Off-pump coronary artery bypass | Active comparator | Procedure: Off-pump coronary artery bypass |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory);
- LAD diseases not suitable for PCI [i.e. chronic totally occlusion (CTO), severe calcification or/and angulated lesions, bifurcation or trifurcation lesions];
- Angiographic characteristics of non-LAD lesion(s) amiable to PCI;
- Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
- Evaluated by both cardiac surgeon and cardiologist together.
Key exclusion criteria (12 listed)
- Need for emergent CABG;
- Prior CABG;
- Prior PCI with stenting within 6 months of study entry;
- Stroke with 6 months of study entry;
- Overt congestive heart failure;
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 |
|---|---|---|
| Minimally invasive direct coronary artery bypassAlso: MIDCABMIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia. | Procedure or surgery | One-stop hybrid revasularization |
| PCI-Drug eluting stentsAlso: PCIPCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB. Device: Polymer-based Sirolimus-Eluting Stents (SES). | Procedure or surgery | One-stop hybrid revasularization |
| Off-pump coronary artery bypassAlso: OPCABProcedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia. | Procedure or surgery | Off-pump coronary artery bypass |
Primary outcome
Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
Time frame: 1 year
8 secondary outcomes
Overall MACCE rate.
Time frame: 30 days after procedure and 2 years after enrollment
Cardiac death.
Time frame: 30 days after procedure, 1 and 2 years after enrollment
Documented myocardial infarction.
Time frame: 30 days after procedure, 1 and 2 years after enrollment
Target lesion revascularization.
Time frame: 30 days after procedure, 1 and 2 years after enrollment
Recurrence of Angina.
Time frame: 1 and 2 years after enrollment
Cost-effectiveness analysis.
Time frame: 1 and 2 years after enrollment
Quality of life.
Time frame: 6 months, 1 and 2 years after enrollment
Rehospitalization.
Time frame: 6 months, 1 and 2 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2009.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Shengshou Hu, M.D. study director
China National Center for Cardiovascular Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive direct coronary artery bypass, PCI-Drug eluting stents and Off-pump coronary artery bypass in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 2 sites 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengshou Hu, M.D. (0086-10-8839-8359, shengshouhu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2009.