Coronary Artery Disease (CAD)HYBRIDNCT01443754
Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease
An observational study of Coronary Artery Disease (CAD), run by Ettore Sansavini Health Science Foundation at 1 site in Italy.
Trial summary
The present study is designed as a prospective, single centre, open label, observational trial. The study will collect information about the medical care patients receive during their planned procedure(s). No new testing or procedures will be done. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- LIMA-LAD surgical revascularization and PCI
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Apr 2016
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients referred to participating sites with clinical indication to revascularization and with clinical characteristics and multi-vessel disease amenable to hybrid revascularization
Who may be able to join
- Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization and fulfilling the following criteria:
- ≥70% left-anterior descendent (LAD) obstruction suitable for surgical revascularization using the left internal mammary artery (LIMA);
- patients amenable to a off-pump beating heart revascularization procedure;
- non-LAD coronary lesions suitable for percutaneous coronary artery intervention (PCI), as adjudicated by one interventional cardiologist and one cardiac surgeon;
- ≥ 70 years of age
- Written informed consent for the use of personal data
Who cannot join
- patients hemodynamically unstable;
- acute or recent (< 1 month) myocardial infarction;
- severe heart failure (NYHA Class IV);
- creatinine > 2.2 mg/dl;
- allergy to radiographic contrast;
- contraindication to double antiaggregation therapy (DAT) for at least 12 months;
Show all 11Show fewer
- previous cardiac surgery of any type;
- previous thoracic surgery involving left pleural space;
- previous coronary stenting: within one month for BMS, within 6 months for DES;
- disabling stroke within previous 6 months;
- need for concomitant cardiac surgery during index hospitalization;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Revascularisation by Combined CABG and PCI in Multivessel Coronary Disease. An Observational Study.
The present study is designed as a prospective, single centre, open label, observational trial.
The study will collect information about the medical care patients receive during their planned procedure(s). No new testing or procedures will be done.
Read more
Patients elected for hybrid revascularization will be asked their written consent to the use of their personal data.
Left internal mammary artery to the Left Anterior Descending Coronary Artery (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous revascularization of the other vessels in the frame of the same hospitalization.
After discharge patients will attend clinic visits at 30 days and 12 months, as per usual clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.
Read the detailed description
Hybrid coronary revascularization integrates the positive features of both Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG), combining the durability of Left Anterior Descending Coronary Artery (LIMA) coronary bypass with the minimal invasiveness and lower risk of percutaneous intervention. Thereby it might represent a better option in a sizeable proportion of patients.
Candidate patients in whom hybrid revascularization would be advantageous are several subgroups of Coronary Artery Disease (CAD) patients that are increasing in numbers: the elderly patients with a high risk of mortality and/or morbidity for CABG, patients with significant disabilities and patients in whom treatment durability is important but a significantly invasive approach is not an option.
There are several potential advantages of the hybrid procedure over conventional CABG in selected patients. These advantages include the avoidance of cardiopulmonary bypass-related morbidity, no aortic manipulation with the LIMA-LAD with the beating heart procedure, less blood loss and decreased transfusions, a shorter recovery time than after conventional CABG and patient's preference for "minimally invasive" surgery.
The investigators hypothesize that in selected patients with diffuse coronary disease, a "hybrid" approach employing a staged revascularisation procedure may allow to lower the surgical risk, increase the completeness and effectiveness of revascularisation and, hopefully, to improve immediate and long term outcome.
To test this hypothesis, a well designed, properly sized, prospective, randomized study is needed. Available data, however, do not provide sufficient information to speculate on a clinically meaningful, yet achievable, effectiveness.
Aim of this observational study is therefore to collect more information on the target population, the clinical outcomes and optimal management in order to inform the design of a comparative effectiveness trial.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- LIMA-LAD surgical revascularization, PCI
- 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.
LIMA-LAD surgical revascularizationProcedure or surgery
Off-pump coronary artery bypass (OPCAB) in which coronary revascularization is performed on the beating heart will be followed, the choice of the technical solutions being left at the discretion of the cardiac surgeon:
- use of a left anterior small thoracotomy (LAST), LIMA harvesting using thoracoscopic methods and manual anastomosis of the LIMA-LAD using a stabilization device;
- minimally invasive direct coronary bypass surgery (MIDCAB). The procedures can be performed alone or in combination with one another.
PCIProcedure or surgery
State of the art drug eluting stent (DES)-based percutaneous coronary intervention will be used by each participating site, according to current international guidelines.
Zotarolimus, everolimus or sirolimus drug-eluting stents will be used in all sites.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid group | Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization (LIMA-LAD surgical revascularization followed by PCI) Receives: Procedure: LIMA-LAD surgical revascularization; Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of major cardiac and cerebrovascular events (MACCE)
composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events:
- Death from any cause
- From cardiovascular causes
- From noncardiovascular causes
- Stroke
- MI
- hospitalization for repeat revascularization procedure
Measured: From date of inclusion until the date of first documented MACCE, assessed up to 12 months
Secondary outcomes (6)
• Procedural success
successful treatment will be declared when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.
Measured: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)
• Procedural and post-procedural blood loss and number of transfusions
Measured: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)
• Recovery time
time to extubation; number of days in ICU; total duration of hospital admission
Measured: from end of intervention up to discharge from the hospital (expected average of hospital stay: 2 weeks)
• New York Heart Association (NYHA) class modification with respect to baseline
Measured: at 12 months post-procedure
Quality of life (SF-12 questionnaire)
Measured: at 12 months post-procedure
Length of time to return to work or normal activities
Measured: from hospital discharge (index hospitalization) up to date of return to work or normal activities assessed up to 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ettore Sansavini Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Del Giglio, MD, Principal investigator, GVM Care & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443754
- Sponsor's protocol ID
- ESREFO04
- Acronym
- HYBRID
- Status last verified
- Feb 2015
- First submitted
- 20 Sep 2011
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Revascularisation by Combined CABG and PCI in Multivessel Coronary Disease. An Observational Study.
- ClinicalTrials.gov ID
- NCT01443754
- Acronym / sponsor ID
- HYBRID / ESREFO04
- Conditions
- Coronary Artery Disease (CAD)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ettore Sansavini Health Science FoundationUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Sep 2011 (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 present study is designed as a prospective, single centre, open label, observational trial.
The study will collect information about the medical care patients receive during their planned procedure(s). No new testing or procedures will be done.
Patients elected for hybrid revascularization will be asked their written consent to the use of their personal data.
Left internal mammary artery to the Left Anterior Descending Coronary Artery (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous revascularization of the other vessels in the frame of the same hospitalization.
After discharge patients will attend clinic visits at 30 days and 12 months, as per usual clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.
Detailed description
Hybrid coronary revascularization integrates the positive features of both Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG), combining the durability of Left Anterior Descending Coronary Artery (LIMA) coronary bypass with the minimal invasiveness and lower risk of percutaneous intervention. Thereby it might represent a better option in a sizeable proportion of patients.
Candidate patients in whom hybrid revascularization would be advantageous are several subgroups of Coronary Artery Disease (CAD) patients that are increasing in numbers: the elderly patients with a high risk of mortality and/or morbidity for CABG, patients with significant disabilities and patients in whom treatment durability is important but a significantly invasive approach is not an option.
There are several potential advantages of the hybrid procedure over conventional CABG in selected patients. These advantages include the avoidance of cardiopulmonary bypass-related morbidity, no aortic manipulation with the LIMA-LAD with the beating heart procedure, less blood loss and decreased transfusions, a shorter recovery time than after conventional CABG and patient's preference for "minimally invasive" surgery.
The investigators hypothesize that in selected patients with diffuse coronary disease, a "hybrid" approach employing a staged revascularisation procedure may allow to lower the surgical risk, increase the completeness and effectiveness of revascularisation and, hopefully, to improve immediate and long term outcome.
To test this hypothesis, a well designed, properly sized, prospective, randomized study is needed. Available data, however, do not provide sufficient information to speculate on a clinically meaningful, yet achievable, effectiveness.
Aim of this observational study is therefore to collect more information on the target population, the clinical outcomes and optimal management in order to inform the design of a comparative effectiveness trial.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid group | – | Procedure: LIMA-LAD surgical revascularization, Procedure: PCIPatients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization (LIMA-LAD surgical revascularization followed by PCI) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients referred to participating sites with clinical indication to revascularization and with clinical characteristics and multi-vessel disease amenable to hybrid revascularization
Key inclusion criteria (6 listed)
- Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization and fulfilling the following criteria:
- ≥70% left-anterior descendent (LAD) obstruction suitable for surgical revascularization using the left internal mammary artery (LIMA);
- patients amenable to a off-pump beating heart revascularization procedure;
- non-LAD coronary lesions suitable for percutaneous coronary artery intervention (PCI), as adjudicated by one interventional cardiologist and one cardiac surgeon;
- ≥ 70 years of age
Key exclusion criteria (11 listed)
- patients hemodynamically unstable;
- acute or recent (< 1 month) myocardial infarction;
- severe heart failure (NYHA Class IV);
- creatinine > 2.2 mg/dl;
- allergy to radiographic contrast;
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 |
|---|---|---|
| LIMA-LAD surgical revascularizationOff-pump coronary artery bypass (OPCAB) in which coronary revascularization is performed on the beating heart will be followed, the choice of the technical solutions being left at the discretion of the cardiac surgeon: * use of a left anterior small thoracotomy (LAST), LIMA harvesting using thoracoscopic methods and manual anastomosis of the LIMA-LAD using a stabilization device; * minimally invasive direct coronary bypass surgery (MIDCAB). The procedures can be performed alone or in combination with one another. | Procedure or surgery | Hybrid group |
| PCIState of the art drug eluting stent (DES)-based percutaneous coronary intervention will be used by each participating site, according to current international guidelines. Zotarolimus, everolimus or sirolimus drug-eluting stents will be used in all sites. | Procedure or surgery | Hybrid group |
Primary outcome
composite of major cardiac and cerebrovascular events (MACCE)
Time frame: From date of inclusion until the date of first documented MACCE, assessed up to 12 months
composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: * Death from any cause * From cardiovascular causes * From noncardiovascular causes * Stroke * MI * hospitalization for repeat revascularization procedure
6 secondary outcomes
• Procedural success
Time frame: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)
• Procedural and post-procedural blood loss and number of transfusions
Time frame: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)
• Recovery time
Time frame: from end of intervention up to discharge from the hospital (expected average of hospital stay: 2 weeks)
• New York Heart Association (NYHA) class modification with respect to baseline
Time frame: at 12 months post-procedure
Quality of life (SF-12 questionnaire)
Time frame: at 12 months post-procedure
Length of time to return to work or normal activities
Time frame: from hospital discharge (index hospitalization) up to date of return to work or normal activities assessed up to 12 months after intervention
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease (CAD)
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
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
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.
Mauro Del Giglio, MD principal investigator
GVM Care & Research
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 Artery Disease (CAD), run by Ettore Sansavini Health Science Foundation at 1 site in Italy.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Oct 2016. 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 Italy. 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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 of major cardiac and cerebrovascular events (MACCE) (time frame: From date of inclusion until the date of first documented MACCE, assessed up to 12 months). 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 3 Oct 2016.