Left Main Coronary Artery DiseasePERHAPSNCT05143671
Prospective Evaluation for Hybrid Cardiac Procedures
An observational study of Left Main Coronary Artery Disease and Left Anterior Descending Coronary Artery Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream in cardiovascular medicine. "Hybrid operative rooms" allow to offer selected heart-disease patients truly "tailored" operations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Main Coronary Artery Disease, Left Anterior Descending Coronary Artery Stenosis, Valve Disease, Heart
- What is being tested?
- Coronary artery bypass grafting, Percutaneous coronary intervention and Surgical valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 134 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2021to 30 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with: * Multi-vessel CAD involving the laft main (LM) and/or the left anterior descending (LAD) artery with indication for revascularization; * Severe, symptomatic valvular disease and CAD with indication for revascularization; * Significant unilateral carotid stenosis and CAD with indication for revascularization.
Who may be able to join
- Signed informed consent, inclusive of release of medical information
- Age ≥ 18 years
- CAD with indication for revascularization
- Coronary anatomy as follows:
- Multivessel-CAD involving the left anterior descending (LAD) (proximal or mid) and/or the left main (LM) (ostial, mid-shaft or distal) with at least one further epicardial coronary artery requiring treatment (LCX or RCA), OR
- Single vessel disease involving the LAD and a major diagonal, both requiring independent revascularization with at least one stent
Show all 12Show fewer
- Severe aortic stenosis/insufficiency and/or mitral stenosis/insufficiency requiring surgery, with CAD (involving one or more vessels), suitable for PCI
- CAD with indication for revascularization with severe unilateral carotid stenosis (>85%)
- Ability to tolerate, and no plans to interrupt dual antiplatelet therapy (DAPT) for:
- At least 6 months in presentation was stable CAD,
- At least 12 months if presentation was a biomarker-positive acute coronary syndrome (ACS)
- Willing to comply with the follow-up required by the protocol.
Who cannot join
- Previous cardiac surgery of any kind
- Previous thoracic surgery involving the left pleural space (if a left thoracotomy approach is planned)
- Complicated or unsuccessful PCI within 30 days prior
- Total occlusion (TIMI 0 or 1 flow) of the LM or LAD
- Cardiogenic shock at time of screening
- Any prior lung resection
Show all 11Show fewer
- End-stage renal disease on dialysis
- Extra-cardiac illness that is expected to limit survival to less then 5 years
- Allergy or hypersensitivity to any of the study drugs or devices used in protocol
- Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgement of the investigator
- Pregnant at time of screening, or unwilling to use effective birth control measures while dual antiplatelet therapy is required.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
About this study
Multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream in cardiovascular medicine. "Hybrid operative rooms" allow to offer selected heart-disease patients truly "tailored" operations.
This study wants to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients in three subgroups of patients:
Read more
- Hybrid coronary revascularization strategy (coronary by-pass + PCI);
- Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
- Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).
The investigators hypothesize that morbidity might be reduced by 50% in hybrid procedures group as compared with predicted Society of Thoracic Surgery (STS) score.
Read the detailed description
Cardiovascular medicine is actually evolving fast and multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream. The possibility to realize combinations of treatments traditionally available only in the catheterization laboratory and in the operating room represent the rationale for "hybrid operative rooms" facilities allowing to offer selected heart-disease patients truly "tailored" operations. Such "Hybrid" management strategies usually combine transcatheter techniques and surgery (often minimally invasive) in order to combine the reduced invasiveness of the former with the effectiveness of the latter. Common examples of surgical and transcatheter combinations are: hybrid revascularization performed with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI); combined heart valve and coronary disease treated with valve surgery and PCI; combined endo- and epicardial ablation of atrial fibrillation; thoracic aneurysms treated with endovascular stenting and surgical debranching of the arch; carotid artery stenting along with CABG. Given the relatively recent development of these techniques, indications and patient selection are yet to be defined and a productive collaboration between surgeons and interventional cardiologists is of paramount importance.
Aim of the study is to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients. Specifically, three subgroups will be analysed:
- Hybrid coronary revascularization strategy (HCR, coronary by-pass + PCI);
- Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
- Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).
The local Heart Team (cardiac surgeon, interventional cardiologist, clinical cardiologist and anaesthetist) will decide which patients will be referred for hybrid treatment. Typically, this happens when the Heart Team feels that hybrid treatment could reduce the overall risk of a combined procedure.
The patient population consists of adult patients with:
- Multi-vessel coronary artery disease (CAD) involving the left main and/or the left anterior descending artery with indication for revascularization;
- Severe, symptomatic valvular disease and CAD with indication for revascularization;
- Significant unilateral carotid stenosis and CAD with indication for revascularization.
In a previous data review board on the Heart Team activity, we recognized that 10% of discussed patients are referred for hybrid procedures (HP) and that observed operative mortality was strongly lower than that predicted by STS and EuroSCORE (2.5% versus 10.1% and 5.9%, respectively). Morbidity was not prospectively investigated. For sample size estimation, the investigators hypothesized that Morbidity might be reduced by 50% in HP group as compared with predicted STS. The mean expected STS morbidity estimated in the study population is 32.57%. Accordingly, a total number of 111 patients with an alpha error of 5% and a beta error of 20% has been calculated to be needed to test this hypothesis.
- Conditions
- Left Main Coronary Artery Disease, Left Anterior Descending Coronary Artery Stenosis, Valve Disease, Heart, Carotid Stenosis, Coronary Artery Disease, Heart Diseases
- Being tested
- Coronary artery bypass grafting, Percutaneous coronary intervention, Surgical valve replacement, Carotid artery stenting
- Keywords
- coronary artery disease, carotid stenosis, percutaneous coronary intervention, coronary artery bypass, carotid artery diseases, heart valves, stent
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Carotid Stenosis, Heart Diseases, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass graftingProcedure or surgery
Coronary artery bypass grafting in coronary revascularization.
Percutaneous coronary interventionProcedure or surgery
Percutaneous coronary intervention in coronary revascularization.
Surgical valve replacementProcedure or surgery
Surgical mitral and / or aortic valve replacement.
Carotid artery stentingProcedure or surgery
Carotid artery stenting.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid coronary revascularization strategy (HCR) | Patients who undergo a combination of coronary artery bypass grafting and PCI. Receives: Procedure: Coronary artery bypass grafting; Procedure: Percutaneous coronary intervention | |
| Hybrid valve and coronary disease correction | Patients who undergo a combination of surgical valve replacement and PCI. Receives: Procedure: Percutaneous coronary intervention; Procedure: Surgical valve replacement | |
| Hybrid coronary and carotid artery disease treatment | Patients who undergo a combination of coronary artery bypass grafting and carotid stenting. Receives: Procedure: Coronary artery bypass grafting; Procedure: Carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with stroke
Rapid onset of a new neurological deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection) that i) persists beyond 24 hours, or ii) less than 24 hours if: a) associated with infarction or hemorrhage on an imaging study, or b) treated with pharmacologic or mechanical intervention, or c) results in death.
Measured: 6 days after operation
Number of participants with renal failure
Acute or worsening renal failure resulting in one or more of the following: 1. Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level. 2. A new requirement for dialysis postoperatively.
Measured: 6 days after operation
Number of participants with prolonged ventilation > 24 hours
Prolonged postoperative pulmonary ventilation > 24.0 hours.
Measured: 25 hours after operative room exit.
Number of participants with deep sternal wound infection
Deep sternal wound infection or mediastinitis (according to Centers for Disease Control (CDC) definition)
Measured: Diagnosis within 30 days of the operation or >30 days after procedure but during hospital stay for surgery.
Number of participants who undergo reoperation
Reoperation for bleeding/tamponade, valvular dysfunction, graft failure, aortic reintervention, or other cardiac reason.
Measured: 6 days after operation
Number of participants with major morbidity or operative mortality
A composite endpoint defined as any of the outcomes listed in the first six rows of this list
Measured: 6 days after operation
Number of participants with short stay
Patient length of stay < 6 days. Discharged alive and within 5 days of surgery
Measured: 6 days after operation
Number of participants with long stay
Patient length of stay > 14 days. Failure to be discharged within 14 days of surgery
Measured: 15 days after operation
Secondary outcomes (6)
Cardiovascular events
Cardiovascular events include: individual components of major adverse cardiac and cerebrovascular events (MACCE) (all-cause mortality, ischemic stroke, miocardial infarction, unplanned revascularization), ischemia-driven revascularization, cardiovascular and non-cardiovascular mortality, stent thrombosis, symptomatic graft stenosis or occlusion, re-hospitalization and othe medical encounters (all-cause and cardiovascular).
Measured: 30 days post procedure and 12 months
Bleeding
Site assessed bleeding complications will be reported using the Bleeding Academic Research Consortium Scale. This scale ranges from Type 0 bleeding to Type 5 b bleeding. The higher the score is, the worse the outcome is.
Measured: 30 days post procedure and 12 months
Rate of one or more additional adverse event.
Rate of one or more additional adverse event among this list:
- Acute renal failure or worsening renal function resulting in one or both of the following: increase in serum creatinine by ≥0.5 mg/dL or ≥25% from baseline, or need for dialysis.
- Atrial fibrillation requiring treatment (including drug therapy, cardioversion or ablation procedures).
- Major arrhythmia (any supraventricular tachycardia requiring cardioversion, ventricular tachycardia or fibrillation requiring treatment, or bradyarrhythmia requiring temporary or permanent pacemaker).
- Sternal wound dehiscence.
- Infection requiring intravenous antibiotics for treatment.
- Intubation lenght >48 hours.
- Respiratory failure defined as continued mechanical ventilation required for greater than 48 hours post operatively.
- Post-pericardiotomy syndrome: an inflammatory response to cardiothoracic surgery.
Measured: 30 days post procedure and 12 months
Health Status through angina assessment.
Angina class measured by the Canadian Cardiovascular Society class. This class ranges from class I to class IV. The higher the class is, the worse the outcome is.
Measured: 30 days post procedure and 12 months
Health Status through quality of life assessment.
Quality of Life will be measured, using the Short Form-12 (SF-12) general health status questionnaire and EuroQoL 5-D (EuroQoL) questionnaire, which measures health state preference from the individual and societal perspective.
Measured: 30 days post procedure and 12 months
Cost-effectiveness
Overall costs of hospitalization and quality-adjusted life expectancy.
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start13 May 2021
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Left Main 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bruno, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Piergiorgio Bruno, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143671
- Sponsor's protocol ID
- 3959
- Acronym
- PERHAPS
- Status last verified
- Aug 2025
- First submitted
- 5 Nov 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Byrne JG, Leacche M, Vaughan DE, Zhao DX. Hybrid cardiovascular procedures. JACC Cardiovasc Interv. 2008 Oct;1(5):459-68. doi: 10.1016/j.jcin.2008.07.002.
PubMed 19463346Leacche M, Umakanthan R, Zhao DX, Byrne JG. Surgical update: hybrid procedures, do they have a role? Circ Cardiovasc Interv. 2010 Oct;3(5):511-8. doi: 10.1161/CIRCINTERVENTIONS.110.957951. No abstract available.
PubMed 20959598Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
PubMed 3484393Diegeler A, Thiele H, Falk V, Hambrecht R, Spyrantis N, Sick P, Diederich KW, Mohr FW, Schuler G. Comparison of stenting with minimally invasive bypass surgery for stenosis of the left anterior descending coronary artery. N Engl J Med. 2002 Aug 22;347(8):561-6. doi: 10.1056/NEJMoa013563.
PubMed 12192015Lytle BW, Cosgrove DM, Loop FD, Borsh J, Goormastic M, Taylor PC. Perioperative risk of bilateral internal mammary artery grafting: analysis of 500 cases from 1971 to 1984. Circulation. 1986 Nov;74(5 Pt 2):III37-41.
PubMed 3490331Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.
PubMed 14726042Ben-Gal Y, Mohr R, Braunstein R, Finkelstein A, Hansson N, Hendler A, Moshkovitz Y, Uretzky G. Revascularization of left anterior descending artery with drug-eluting stents: comparison with minimally invasive direct coronary artery bypass surgery. Ann Thorac Surg. 2006 Dec;82(6):2067-71. doi: 10.1016/j.athoracsur.2006.06.041.
PubMed 17126111Fraund S, Herrmann G, Witzke A, Hedderich J, Lutter G, Brandt M, Boning A, Cremer J. Midterm follow-up after minimally invasive direct coronary artery bypass grafting versus percutaneous coronary intervention techniques. Ann Thorac Surg. 2005 Apr;79(4):1225-31. doi: 10.1016/j.athoracsur.2004.08.082.
PubMed 15797053Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB Jr, Lorenz TJ, Goyal A, Gibson M, Mack MJ, Gennevois D, Califf RM, Kouchoukos NT; PREVENT IV Investigators. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2446-54. doi: 10.1001/jama.294.19.2446.
PubMed 16287955Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
PubMed 14523139Harskamp RE, Zheng Z, Alexander JH, Williams JB, Xian Y, Halkos ME, Brennan JM, de Winter RJ, Smith PK, Lopes RD. Status quo of hybrid coronary revascularization for multi-vessel coronary artery disease. Ann Thorac Surg. 2013 Dec;96(6):2268-77. doi: 10.1016/j.athoracsur.2013.07.093.
PubMed 24446561Mauri L, Orav EJ, Kuntz RE. Late loss in lumen diameter and binary restenosis for drug-eluting stent comparison. Circulation. 2005 Jun 28;111(25):3435-42. doi: 10.1161/CIRCULATIONAHA.104.513952. Epub 2005 Jun 20.
PubMed 15967844Leacche M, Byrne JG, Solenkova NS, Reagan B, Mohamed TI, Fredi JL, Zhao DX. Comparison of 30-day outcomes of coronary artery bypass grafting surgery verus hybrid coronary revascularization stratified by SYNTAX and euroSCORE. J Thorac Cardiovasc Surg. 2013 Apr;145(4):1004-1012. doi: 10.1016/j.jtcvs.2012.03.062. Epub 2012 Apr 25.
PubMed 22541514Harskamp RE, Brennan JM, Xian Y, Halkos ME, Puskas JD, Thourani VH, Gammie JS, Taylor BS, de Winter RJ, Kim S, O'Brien S, Peterson ED, Gaca JG. Practice patterns and clinical outcomes after hybrid coronary revascularization in the United States: an analysis from the society of thoracic surgeons adult cardiac database. Circulation. 2014 Sep 9;130(11):872-9. doi: 10.1161/CIRCULATIONAHA.114.009479. Epub 2014 Jul 23.
PubMed 25055814Verhaegh AJ, Accord RE, van Garsse L, Maessen JG. Hybrid coronary revascularization as a safe, feasible, and viable alternative to conventional coronary artery bypass grafting: what is the current evidence? Minim Invasive Surg. 2013;2013:142616. doi: 10.1155/2013/142616. Epub 2013 Apr 3.
PubMed 23691303
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation for Hybrid Cardiac Procedures
- ClinicalTrials.gov ID
- NCT05143671
- Acronym / sponsor ID
- PERHAPS / 3959
- Conditions
- Left Main Coronary Artery Disease, Left Anterior Descending Coronary Artery Stenosis, Valve Disease, Heart, Carotid Stenosis, Coronary Artery Disease, Heart Diseases
- Keywords
- coronary artery disease, carotid stenosis, percutaneous coronary intervention, coronary artery bypass, carotid artery diseases, heart valves, stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 3 Dec 2021 (actual)
- 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.
Multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream in cardiovascular medicine. "Hybrid operative rooms" allow to offer selected heart-disease patients truly "tailored" operations.
This study wants to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients in three subgroups of patients:
- Hybrid coronary revascularization strategy (coronary by-pass + PCI);
- Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
- Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).
The investigators hypothesize that morbidity might be reduced by 50% in hybrid procedures group as compared with predicted Society of Thoracic Surgery (STS) score.
Detailed description
Cardiovascular medicine is actually evolving fast and multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream. The possibility to realize combinations of treatments traditionally available only in the catheterization laboratory and in the operating room represent the rationale for "hybrid operative rooms" facilities allowing to offer selected heart-disease patients truly "tailored" operations. Such "Hybrid" management strategies usually combine transcatheter techniques and surgery (often minimally invasive) in order to combine the reduced invasiveness of the former with the effectiveness of the latter. Common examples of surgical and transcatheter combinations are: hybrid revascularization performed with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI); combined heart valve and coronary disease treated with valve surgery and PCI; combined endo- and epicardial ablation of atrial fibrillation; thoracic aneurysms treated with endovascular stenting and surgical debranching of the arch; carotid artery stenting along with CABG. Given the relatively recent development of these techniques, indications and patient selection are yet to be defined and a productive collaboration between surgeons and interventional cardiologists is of paramount importance.
Aim of the study is to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients. Specifically, three subgroups will be analysed:
- Hybrid coronary revascularization strategy (HCR, coronary by-pass + PCI);
- Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
- Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).
The local Heart Team (cardiac surgeon, interventional cardiologist, clinical cardiologist and anaesthetist) will decide which patients will be referred for hybrid treatment. Typically, this happens when the Heart Team feels that hybrid treatment could reduce the overall risk of a combined procedure.
The patient population consists of adult patients with:
- Multi-vessel coronary artery disease (CAD) involving the left main and/or the left anterior descending artery with indication for revascularization;
- Severe, symptomatic valvular disease and CAD with indication for revascularization;
- Significant unilateral carotid stenosis and CAD with indication for revascularization.
In a previous data review board on the Heart Team activity, we recognized that 10% of discussed patients are referred for hybrid procedures (HP) and that observed operative mortality was strongly lower than that predicted by STS and EuroSCORE (2.5% versus 10.1% and 5.9%, respectively). Morbidity was not prospectively investigated. For sample size estimation, the investigators hypothesized that Morbidity might be reduced by 50% in HP group as compared with predicted STS. The mean expected STS morbidity estimated in the study population is 32.57%. Accordingly, a total number of 111 patients with an alpha error of 5% and a beta error of 20% has been calculated to be needed to test this hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hybrid coronary revascularization strategy (HCR) | – | Procedure: Coronary artery bypass grafting, Procedure: Percutaneous coronary interventionPatients who undergo a combination of coronary artery bypass grafting and PCI. |
| Hybrid valve and coronary disease correction | – | Procedure: Percutaneous coronary intervention, Procedure: Surgical valve replacementPatients who undergo a combination of surgical valve replacement and PCI. |
| Hybrid coronary and carotid artery disease treatment | – | Procedure: Coronary artery bypass grafting, Procedure: Carotid artery stentingPatients who undergo a combination of coronary artery bypass grafting and carotid stenting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with: * Multi-vessel CAD involving the laft main (LM) and/or the left anterior descending (LAD) artery with indication for revascularization; * Severe, symptomatic valvular disease and CAD with indication for revascularization; * Significant unilateral carotid stenosis and CAD with indication for revascularization.
Key inclusion criteria (12 listed)
- Signed informed consent, inclusive of release of medical information
- Age ≥ 18 years
- CAD with indication for revascularization
- Coronary anatomy as follows:
- Severe aortic stenosis/insufficiency and/or mitral stenosis/insufficiency requiring surgery, with CAD (involving one or more vessels), suitable for PCI
Key exclusion criteria (11 listed)
- Previous cardiac surgery of any kind
- Previous thoracic surgery involving the left pleural space (if a left thoracotomy approach is planned)
- Complicated or unsuccessful PCI within 30 days prior
- Total occlusion (TIMI 0 or 1 flow) of the LM or LAD
- Cardiogenic shock at time of screening
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 |
|---|---|---|
| Coronary artery bypass graftingCoronary artery bypass grafting in coronary revascularization. | Procedure or surgery | Hybrid coronary and carotid artery disease treatment, Hybrid coronary revascularization strategy (HCR) |
| Percutaneous coronary interventionPercutaneous coronary intervention in coronary revascularization. | Procedure or surgery | Hybrid coronary revascularization strategy (HCR), Hybrid valve and coronary disease correction |
| Surgical valve replacementSurgical mitral and / or aortic valve replacement. | Procedure or surgery | Hybrid valve and coronary disease correction |
| Carotid artery stentingCarotid artery stenting. | Procedure or surgery | Hybrid coronary and carotid artery disease treatment |
Primary outcome
Number of participants with stroke
Time frame: 6 days after operation
Rapid onset of a new neurological deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection) that i) persists beyond 24 hours, or ii) less than 24 hours if: a) associated with infarction or hemorrhage on an imaging study, or b) treated with pharmacologic or mechanical intervention, or c) results in death.
Number of participants with renal failure
Time frame: 6 days after operation
Acute or worsening renal failure resulting in one or more of the following: 1. Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level. 2. A new requirement for dialysis postoperatively.
Number of participants with prolonged ventilation > 24 hours
Time frame: 25 hours after operative room exit.
Prolonged postoperative pulmonary ventilation > 24.0 hours.
Number of participants with deep sternal wound infection
Time frame: Diagnosis within 30 days of the operation or >30 days after procedure but during hospital stay for surgery.
Deep sternal wound infection or mediastinitis (according to Centers for Disease Control (CDC) definition)
Number of participants who undergo reoperation
Time frame: 6 days after operation
Reoperation for bleeding/tamponade, valvular dysfunction, graft failure, aortic reintervention, or other cardiac reason.
Number of participants with major morbidity or operative mortality
Time frame: 6 days after operation
A composite endpoint defined as any of the outcomes listed in the first six rows of this list
Number of participants with short stay
Time frame: 6 days after operation
Patient length of stay < 6 days. Discharged alive and within 5 days of surgery
Number of participants with long stay
Time frame: 15 days after operation
Patient length of stay > 14 days. Failure to be discharged within 14 days of surgery
6 secondary outcomes
Cardiovascular events
Time frame: 30 days post procedure and 12 months
Bleeding
Time frame: 30 days post procedure and 12 months
Rate of one or more additional adverse event.
Time frame: 30 days post procedure and 12 months
Health Status through angina assessment.
Time frame: 30 days post procedure and 12 months
Health Status through quality of life assessment.
Time frame: 30 days post procedure and 12 months
Cost-effectiveness
Time frame: 12 months post procedure
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 14 Aug 2025.
- Background: PubMed 19463346Byrne JG, Leacche M, Vaughan DE, Zhao DX. Hybrid cardiovascular procedures. JACC Cardiovasc Interv. 2008 Oct;1(5):459-68. doi: 10.1016/j.jcin.2008.07.002.
- Background: PubMed 20959598Leacche M, Umakanthan R, Zhao DX, Byrne JG. Surgical update: hybrid procedures, do they have a role? Circ Cardiovasc Interv. 2010 Oct;3(5):511-8. doi: 10.1161/CIRCINTERVENTIONS.110.957951. No abstract available.
- Background: PubMed 3484393Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
- Background: PubMed 12192015Diegeler A, Thiele H, Falk V, Hambrecht R, Spyrantis N, Sick P, Diederich KW, Mohr FW, Schuler G. Comparison of stenting with minimally invasive bypass surgery for stenosis of the left anterior descending coronary artery. N Engl J Med. 2002 Aug 22;347(8):561-6. doi: 10.1056/NEJMoa013563.
- Background: PubMed 3490331Lytle BW, Cosgrove DM, Loop FD, Borsh J, Goormastic M, Taylor PC. Perioperative risk of bilateral internal mammary artery grafting: analysis of 500 cases from 1971 to 1984. Circulation. 1986 Nov;74(5 Pt 2):III37-41.
- Background: PubMed 14726042Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.
- Background: PubMed 17126111Ben-Gal Y, Mohr R, Braunstein R, Finkelstein A, Hansson N, Hendler A, Moshkovitz Y, Uretzky G. Revascularization of left anterior descending artery with drug-eluting stents: comparison with minimally invasive direct coronary artery bypass surgery. Ann Thorac Surg. 2006 Dec;82(6):2067-71. doi: 10.1016/j.athoracsur.2006.06.041.
- Background: PubMed 15797053Fraund S, Herrmann G, Witzke A, Hedderich J, Lutter G, Brandt M, Boning A, Cremer J. Midterm follow-up after minimally invasive direct coronary artery bypass grafting versus percutaneous coronary intervention techniques. Ann Thorac Surg. 2005 Apr;79(4):1225-31. doi: 10.1016/j.athoracsur.2004.08.082.
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- Individual participant dataSharing planned: Undecided
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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.
Piergiorgio Bruno, MD principal investigator
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 Left Main Coronary Artery Disease and Left Anterior Descending Coronary Artery Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 12 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: finished, as of the sponsor's last update on 14 Aug 2025. 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 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?
Number of participants with stroke (time frame: 6 days after operation). The study lists 8 primary outcomes in all. 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 NCT05143671, which also lists 38 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 14 Aug 2025.