An observational study in Aortic Stenosis Disease and Coronary Artery Disease (CAD), sponsored by Alexandria University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Alexandria University · Observational
# WHAT IS THIS STUDY ABOUT?
This study compares two different treatment approaches for patients with two heart conditions occurring simultaneously: a narrowed heart valve (aortic stenosis) and narrowed or blocked heart arteries (coronary artery disease). Both conditions are serious and, when they occur together, place considerable strain on the heart. The heart must work harder to pump blood through the narrowed valve while simultaneously receiving an inadequate blood supply through the blocked coronary arteries.
# WHY IS THIS STUDY NEEDED?
Until recently, the main treatment option for patients with both conditions was open-heart surgery. This major operation involves opening the chest, temporarily stopping the heart, replacing the heart valve with an artificial valve, and performing coronary artery bypass grafting to restore blood flow around the blocked arteries. Although effective, combined surgery carries significant risks, particularly in older or frailer patients, including prolonged recovery, longer hospital stays (often 2 to 3 weeks), bleeding, kidney injury, and other complications.
A newer, less invasive treatment approach is now available. This involves replacing the heart valve through a thin tube (catheter) inserted through a blood vessel in the groin, without opening the chest, and treating the blocked coronary arteries using a fine wire, a small balloon, and a metal mesh tube (stent) placed inside the artery. This approach, known as transcatheter aortic valve implantation (TAVI) combined with percutaneous coronary intervention (PCI), typically requires a shorter hospital stay of approximately 2 to 4 days and may allow an earlier return to normal activities.
However, sufficient evidence from well-designed studies is not yet available to establish whether this less invasive approach is as safe and effective as conventional surgery in patients who are not considered at high surgical risk.
This study aims to address this evidence gap.
# WHO CAN JOIN THIS STUDY?
Adults with severe aortic stenosis and significant coronary artery disease who have been assessed by a specialist heart team as having low or intermediate surgical risk may be eligible to participate.
All participants must be considered suitable for both the catheter-based treatment approach and the surgical approach, based on individual coronary anatomy, clinical characteristics, and medical history.
Patients with previous coronary artery bypass graft surgery, severely impaired left ventricular systolic function (ejection fraction below 40%), or a recent myocardial infarction within the previous 6 months are not eligible to participate.
Participants will receive one of two treatment approaches, selected by a specialist heart team according to individual coronary and valvular anatomy, clinical circumstances, and patient preference:
Conventional open-heart surgery involving surgical aortic valve replacement and coronary artery bypass grafting (SAVR + CABG).
Regardless of the treatment received, all participants will undergo follow-up assessments at hospital discharge, 30 days, 6 months, and 1 year after the procedure. Follow-up will include clinical assessments and appropriate cardiac investigations.
The study will evaluate the incidence of major complications, including all-cause mortality, myocardial infarction, stroke, serious bleeding, and the need for urgent repeat intervention, during the index hospitalization and within 1 year after the procedure.
Additional outcomes will include recovery duration, length of hospital stay, and changes in kidney function.
The study is being conducted at Alexandria University Hospitals and other major cardiac centres across Egypt, with a planned total enrolment of 100 participants.
# WHO IS CONDUCTING THE STUDY?
The study is being conducted by Dr. Moustafa AbdelMohsen Elsayed Madkour, Department of Cardiology and Angiology, Faculty of Medicine, Alexandria University, Egypt, under the supervision of Prof. Dr. Mohamed Ahmed Sobhy and Prof. Dr. Tarek Hussien Elzawawy.
Severe aortic stenosis (AS) is the most common valvular heart disease requiring intervention in adults, affecting approximately 2-5% of individuals over 65 years of age. Coronary artery disease (CAD) coexists in 50-75% of patients referred for treatment of severe AS, reflecting shared risk factors and pathophysiological mechanisms, including active fibrocalcific valve disease with similarities to atherosclerosis. The simultaneous presence of both conditions creates a complex hemodynamic environment. AS-related left ventricular pressure overload induces concentric hypertrophy, reduces capillary density, elevates left ventricular end-diastolic pressure, impairs coronary flow reserve, and contributes to chronic subendocardial ischemia, even in the absence of significant epicardial coronary disease. The coexistence of significant epicardial CAD further aggravates the myocardial oxygen supply-demand imbalance, potentially accelerating clinical deterioration and worsening cardiovascular outcomes.
An additional complexity involves the assessment of coronary lesion severity using fractional flow reserve (FFR), a standard invasive index for evaluating the functional significance of coronary stenoses. In the setting of severe AS, altered coronary hemodynamics and impaired hyperemic responses may affect FFR measurements, potentially resulting in overestimation of FFR values and underestimation of the functional significance of coronary lesions. The instantaneous wave-free ratio (iFR) appears comparatively less affected by these hemodynamic changes and may provide an alternative physiological assessment in patients with severe AS.
For decades, surgical aortic valve replacement (SAVR) combined with coronary artery bypass grafting (CABG) has been the standard treatment strategy for surgically eligible patients with concomitant AS and CAD. This approach provides the potential for complete and durable myocardial revascularization but is associated with substantial operative morbidity, including 30-day mortality rates of approximately 4-8% in intermediate-risk populations, mean hospital stays of 8-14 days, cardiopulmonary bypass-related acute kidney injury, neurocognitive complications, and bleeding.
The development and progressive expansion of transcatheter aortic valve implantation (TAVI) have introduced an alternative treatment strategy for patients with severe AS. Landmark clinical trials, including PARTNER 2, PARTNER 3, Evolut Low Risk, and DEDICATE-DZHK6 (2024), have demonstrated non-inferiority or superiority of TAVI compared with SAVR across selected low- and intermediate-surgical-risk populations. The combination of TAVI and percutaneous coronary intervention (PCI) offers a fully percutaneous treatment alternative that avoids median sternotomy and cardiopulmonary bypass.
Despite these advantages, the TAVI + PCI strategy presents several clinical challenges. The optimal timing of PCI in relation to TAVI remains a subject of ongoing debate. Coronary re-engagement following TAVI may be technically challenging or restricted by the implanted prosthetic valve frame, with reported failure rates in selected settings. Furthermore, PCI may result in incomplete coronary revascularization compared with surgical bypass, particularly in patients with complex multivessel coronary disease.
Robust prospective comparative evidence evaluating TAVI + PCI versus SAVR + CABG in patients with low and intermediate surgical risk remains limited. Existing evidence from retrospective registries has demonstrated conflicting findings, with some studies reporting lower in-hospital mortality following TAVI + PCI, while others have shown differences in long-term outcomes potentially favouring SAVR + CABG. Prospective comparative studies with standardized endpoint definitions and adjudication specifically addressing this patient population remain necessary.
The present study aims to contribute prospective comparative evidence regarding the clinical outcomes and safety of TAVI + PCI versus SAVR + CABG in patients with concomitant severe AS and significant CAD who are considered at low or intermediate surgical risk.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 100 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
This prospective comparative study will include 100 patients with severe aortic stenosis (AS) and significant coronary artery disease (CAD) who are classified as low or intermediate surgical risk, as determined by the Society of Thoracic Surgeons (STS) risk score (≤8%) and a multidisciplinary Heart Team evaluation (10, 11). Patients will undergo either TAVI with PCI or SAVR with CABG, based on individual clinical suitability, anatomical considerations and patients' preference.
Participants will be enrolled from Alexandria university hospitals and other high-volume tertiary cardiac centers across Egypt.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A. Dyspnea. B. Angina. C. Syncope. D. Decline in \<50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity >5.5 m/s, severe valve calcification or peak transaortic velocity progression ≥0.3 m/s per year, ) according to current guidelines.(1)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
transcatheter aortic valve replacment together with percautaneous coronary intervention either in the same setting or separety
Procedure: TAVI · Procedure: PCI
surgical coronary artery bypass together with aortic valve replacment in the same setting
Procedure: SAVR · Procedure: CABG
transcatheter aortic valve intervention
percautaneous coronary intervention
surgical aortic valve replacment
coronary artery bypass graft
In-Hospital Composite Endpoint
he occurrence of at least one of the following events periprocedurally from the index procedure through hospital discharge, reported as the number and percentage of participants experiencing one or more events: All-cause in-hospital mortality. Non-fatal myocardial infarction. Non-fatal stroke or transient ischemic attack (TIA). Emergency coronary or valve reintervention. High-degree atrioventricular (AV) block. Major bleeding (Bleeding Academic Research Consortium \[BARC\] type ≥3). Each participant will be counted only once in the composite endpoint, regardless of the number of events experienced.
Time frame: Periprocedurally
One-Year Composite Endpoint
he occurrence of at least one of the following events within 12 months after the index procedure: All-cause mortality. Non-fatal myocardial infarction. Non-fatal stroke or transient ischemic attack (TIA). High-degree atrioventricular (AV) block. Major bleeding (Bleeding Academic Research Consortium \[BARC\] type ≥3). The composite endpoint will be reported as the number and percentage of participants experiencing at least one of the listed events. Each participant will be counted only once, regardless of the number of events experienced.
Time frame: within 12 months after the procedure
All-cause mortality
Measure: All-cause mortality Description: Number and percentage of participants who died from any cause. Unit: Participants
Time frame: Within 12 months after the index procedure.
Non-fatal myocardial infarction
Measure: Non-fatal myocardial infarction. Description: Number and percentage of participants experiencing non-fatal myocardial infarction. Unit: Participants
Time frame: Within 12 months after the index procedure.
Non-fatal stroke or TIA
Measure: Non-fatal stroke or transient ischemic attack (TIA) Description: Number and percentage of participants experiencing non-fatal stroke or TIA. Unit: Participants
Time frame: Within 12 months after the index procedure.
High-degree heart block
Measure: High-degree atrioventricular (AV) block Description: Number and percentage of participants developing high-degree AV block. Unit: Participants
Time frame: Within 12 months after the index procedure.
Major bleeding
Measure: Major bleeding (BARC type ≥3) Description: Number and percentage of participants experiencing major bleeding classified as BARC type 3 or higher. Unit: Participants
Time frame: Within 12 months after the index procedure.
Plan to share: No — Individual participant data (IPD) will not be shared publicly because the dataset contains potentially identifiable clinical information. Data will be securely stored and accessible only to the research team. Anonymized aggregate results will be reported in accordance with applicable ethical and institutional requirements.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for May 2027, 15 months after the start.
Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 15 months is below that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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