Coronary Artery DiseaseNCT00928356
A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease
A study testing Hybrid CABG/PCI and Off Pump CABG in people with Coronary Artery Disease, run by Pinnacle Health Cardiovascular Institute at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety and effectiveness of same sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary artery disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Hybrid CABG/PCI and Off Pump CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2008to 13 Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Requirement for CABG
- Anatomy and body habitus suitable for Robotic CABG
- Requirement of revascularization of arteries amendable for PCI but not accessable by Robotic CABG
Who cannot join
- Need for emergent CABG
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17011
About this study
The primary objective of this study is to assess the safety and effectiveness of same sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary artery disease. A secondary objective is the assessment and standardization of optimal operator techniques and comparative study of patients undergoing CABG during study period.
Read the detailed description
The study population will consist of patients with multivessel coronary artery disease requiring CABG with suitable anatomy for combination CABG and PCI of non-bypassed arteries.
The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.
The secondary endpoints include:
- Successful completion of same sitting CABG and coronary stent procedure
- Successful completion of CABG and PCI during single hospitalization
- Achievement of complete revascularization
- Patency of the LIMA and stented vessels as determined by coronary angiography at time of procedures or prior to discharge and by cardiac Computed Tomographic Angiography (CTA) or coronary angiography at 1 year.
- Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)
- One-year composite clinical event endpoints of major clinical events including death, repeat revascularization, myocardial infarction, and freedom from angina
- Comparative analysis of hospital, 30 day, and 1 year events of hybrid CABG patients compared to consecutive patients undergoing off pump CABG with standard thoracotomy during study period
- Conditions
- Coronary Artery Disease
- Being tested
- Hybrid CABG/PCI, Off Pump CABG
- Keywords
- Coronary Artery Disease, Robotic Coronary Artery Bypass Surgery, Percutaneous Coronary Intervention, Hybrid Coronary Revascularization
- 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.
Hybrid CABG/PCIProcedure or surgery
Same sitting hybrid, robotic CABG/PCI
Off Pump CABGProcedure or surgery
Standard of Care Off Pump CABG
| Study group | Role | What they receive |
|---|---|---|
| Hybrid CABG/PCI | Experimental | Patients undergo hybrid, same sitting CABG/PCI as described. Receives: Procedure: Hybrid CABG/PCI |
| Off-pump CABG | Other | Standard of Care Off Pump CABG Receives: Procedure: Off Pump CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.
Measured: 1 year
Secondary outcomes (1)
One-year composite clinical event endpoints of major clinical events. Comparative analysis of consecutive patients undergoing off pump CABG with standard thoracotomy during study period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study start14 Oct 2008
- Primary completion19 May 2015
- Study completion13 Aug 2019
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinnacle Health Cardiovascular Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- William Bachinsky, M.D., Principal investigator, Pinnacle Health Cardiovascular Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928356
- Sponsor's protocol ID
- Same Sitting Robotic CABG/PCI
- Status last verified
- Mar 2019
- First submitted
- 23 Jun 2009
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00928356
- Acronym / sponsor ID
- Same Sitting Robotic CABG/PCI
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Robotic Coronary Artery Bypass Surgery, Percutaneous Coronary Intervention, Hybrid Coronary Revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Pinnacle Health Cardiovascular InstituteResearch network
- Study start
- 14 Oct 2008 (actual)
- Primary completion
- 19 May 2015 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 25 Jun 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 primary objective of this study is to assess the safety and effectiveness of same sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary artery disease. A secondary objective is the assessment and standardization of optimal operator techniques and comparative study of patients undergoing CABG during study period.
Detailed description
The study population will consist of patients with multivessel coronary artery disease requiring CABG with suitable anatomy for combination CABG and PCI of non-bypassed arteries.
The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.
The secondary endpoints include:
- Successful completion of same sitting CABG and coronary stent procedure
- Successful completion of CABG and PCI during single hospitalization
- Achievement of complete revascularization
- Patency of the LIMA and stented vessels as determined by coronary angiography at time of procedures or prior to discharge and by cardiac Computed Tomographic Angiography (CTA) or coronary angiography at 1 year.
- Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)
- One-year composite clinical event endpoints of major clinical events including death, repeat revascularization, myocardial infarction, and freedom from angina
- Comparative analysis of hospital, 30 day, and 1 year events of hybrid CABG patients compared to consecutive patients undergoing off pump CABG with standard thoracotomy during study period
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid CABG/PCI | Experimental | Procedure: Hybrid CABG/PCIPatients undergo hybrid, same sitting CABG/PCI as described. |
| Off-pump CABG | Other | Procedure: Off Pump CABGStandard of Care Off Pump CABG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Requirement for CABG
- Anatomy and body habitus suitable for Robotic CABG
- Requirement of revascularization of arteries amendable for PCI but not accessable by Robotic CABG
Key exclusion criteria (1 listed)
- Need for emergent CABG
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 |
|---|---|---|
| Hybrid CABG/PCISame sitting hybrid, robotic CABG/PCI | Procedure or surgery | Hybrid CABG/PCI |
| Off Pump CABGStandard of Care Off Pump CABG | Procedure or surgery | Off-pump CABG |
Primary outcome
The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.
Time frame: 1 year
1 secondary outcome
One-year composite clinical event endpoints of major clinical events. Comparative analysis of consecutive patients undergoing off pump CABG with standard thoracotomy during study period.
Time frame: 1 year
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 11 May 2020.
- Pinnacle Health Cardiovascular InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
William Bachinsky, M.D. principal investigator
Pinnacle Health Cardiovascular Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid CABG/PCI and Off Pump CABG in people with Coronary Artery Disease, run by Pinnacle Health Cardiovascular Institute at 1 site in United States.
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 11 May 2020. 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 United States. 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?
The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction. (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 11 May 2020.