Carotid StenosisSIM-GUARDNCT04973579
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
An observational study of Carotid Stenosis and Coronary Artery Disease, run by John Paul II Hospital, Krakow at 1 site in Poland.
Trial summary
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis, Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2021to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All-comers registry of patients with Heart and NeuroVascular Team recommendation for single-stage simultaneous surgical and endovascular procedure. The SIM-GUARD single arm registry design and exploratory nature precluded sample size calculation. The number of patients to be enrolled is selected based on the number of procedures at the Center and the average typical size of studies/registries in this field of interventional treatment.
Who may be able to join
- Patients eligible for concomitant carotid artery stenting in conjunction with cardiac surgery based on Heart Team and NeuroVascular Team reccomendation and according to local standards of practice.
- Signed informed consent form
- Consent to (routinely performed in this group of patients) follow-up visits and tests performed (routinely) during long-term follow-up
- De novo atherosclerotic lesions or neo-atherosclerosis.
- Symptomatic patients (with a history of ipsilateral transient cerebral ischemia, stroke or amaurosis fugax within the past 6 months) with carotid artery stenosis ≥50% as assessed by NASCET angiography or
- Asymptomatic patients with carotid artery stenosis ≥70-80% as assessed by angiography (NASCET method).
- Coronary angiography-confirmed multivessel disease or left main stem stenosis with the symptoms of unstable angina or non-ST-segment elevation myocardial infarction.
- Severe symptomatic valvular disease detected by echocardiography.
Who cannot join
- Expected survival time <1 year (e.g., cancer).
- Renal failure with GFR < 20 ml/min/1.73 m2 as calculated by the CKD-EPI formula
- Women who are pregnant (pregnancy test).
- Coagulopathies.
- History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy.
- Total carotid artery occlusion.
Show all 13Show fewer
- Stent in the carotid artery that protrudes into the aortic arch.
- Anatomic variants that preclude stent implantation.
- Significant stenosis of the common carotid artery proximal to the target lesion.
- Mobile atherosclerotic plaques in the aortic arch.
- Anatomy of the coronary arteries unsuitable for bypass grafting.
- Lack of available vascular material for grafting.
- Porcelain aorta.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, 31-202
Piotr Musialek, MD, DPhil, +48126142287, pmusialek@szpitaljp2.krakow.pl
About this study
Official title: SIMultaneous Urgent Cardiac Surgery and Endovascular Stroke Prevention Using the Micronet-covered CGUARD Stent in Hemodynamically Compromised Patients at Increased Peri-operative Stroke Risk: SIM-GUARD Study
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and/or valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study.
Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.
Read the detailed description
The coexistence of symptomatic or unstable stroke-threatening carotid atherosclerotic stenosis with cardiac disease requiring urgent / fast-track cardiac surgery (such as advanced unstable or multivessel coronary artery disease, recent myocardial infarction or pulmonary edema, severely impaired myocardial contractility, and/or severe valvular disease requiring surgical treatment) represents a major medical and therapeutic/logistics challenge.
According to current guidelines, in absence of prospective randomized evidence, the most appropriate management strategy for a given patient should be determined by a multispecialty team. In hemodynamically compromised patients sequential treatment (i.e., first carotid stenosis repair followed by surgery or first cardiac surgery followed by carotid stenosis treatment, either surgical or endovascular) is associated with a high risk of cardiac complications in case of first-stage carotid stenosis treatment and a high risk of neurological complications in case of the first-stage cardiac surgery.
In this challenging patient group, we have introduced single-stage, truly simultaneous procedure. The fundament of the strategy is to establish extracorporeal circulation back-up ("CEC standby") prior to the minimally invasive (endovascular) treatment of stroke-threatening carotid artery stenosis in the hybrid room under single anesthesia.
For CAS (proximal or distal protected), in case of suboptimal femoral access (or lack of femoral access), a direct access via carotid artery is used (transcervical or transcarotid revascularization), this is immediately followed by cardiac surgery.
The procedure, each time, follows recommendation of the Multispecialty Team (Heart Team + NeuroVascular Team) as the lowest-deemed risk management in patients with indications for both urgent both carotid revascularization and cardiac surgery. Both carotid and cardiac treatment are performed under single anesthesia with the feasibility of immediate extracorporeal circulation support during carotid revascularization in case of hemodynamic collapse.
Eligibility for treatment is based on the decision (recommendation) of a multidisciplinary Heart Team along with a NeuroVascular Team consisting of a cardiac surgeon, cardiologist, anesthesiologist, angiologist, neurologist, and vascular surgeon, with the concomitant use of routine pharmacotherapy and non-pharmacological prevention - according to current guidelines.
- Conditions
- Carotid Stenosis, Coronary Artery Disease, Valvular Heart Disease, Myocardial Infarction, Pulmonary Edema With Heart Failure
- Being tested
- Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
- Keywords
- Carotid Stenosis, Coronary Artery Disease, Valvular Disease, Heart Failure, Pulmonary Edema, Single Anesthesia, Simultaneous Procedure
- Medical subject headings
- Carotid Stenosis, Coronary Artery Disease, Heart Valve Diseases, Myocardial Infarction, Heart Failure, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)Procedure or surgery
The registry enrolls patients qualified for treatment with the methods evaluated in the registry, using routinely applicable procedures and devices.
In cardiac surgery - surgical treatment systems for advanced ischemic heart disease and/or valvular disease (including - mechanical/biologic heart valves - regulatory approved for routine use and typically used at the Facility.
In the simultaneous treatment of stroke-threatening carotid artery atherosclerosis - temporary neuroprotection systems (proximal, distal, according to medical indications and local experience) - regulatory approved for routine use and typically used at the center (for over 20 years).
CGuard anti-embolic mesh stent system - a self-expanding nitinol carotid stent wrapped in MicroNet, which prevents fragments of atherosclerotic plaque from entering the lumen of the carotid artery - approved for routine use and typically used at the Center (over 5 years).
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous cardiac surgery and carotid stenting | Patients with Heart Team and NeuroVascular Team recommendation to perform simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) including proximal or distal neuroembolic protection and cardiac surgery (CABG or surgical valve replacement / repair procedure) Receives: Procedure: Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
Freedom from any death, any stroke, and myocardial infarction at 30-day follow-up
Measured: 30 days from index procedure
Secondary outcomes (21)
Freedom from major clinical complications comprising MACNE at 6 months
Freedom from any death, any stroke, and myocardial infarction at 6 months follow-up
Measured: At 6 months from index procedure
Freedom from major clinical complications comprising MACNE at 12 months
Freedom from any death, any stroke, and myocardial infarction at 12 months follow-up
Measured: At 12 months from index procedure
Procedural success rate for carotid stenting
Success of endovascular treatment of carotid artery stenosis i.e. technical success (stent delivery and implantation, withdrawal of stent delivery system, residual stenosis ≤30% of vessel lumen diameter) plus clinical success (procedure without complications).
Measured: Periprocedural
Technical success
Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures
Measured: At the procedure completion
Clinical success
Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures in absence of stroke
Measured: Day 2 after procedure
Rate of arterial access complications
Peri-procedural vascular access complications of carotid artery stenting (pseudoaneurysm of the femoral artery, acute ischemia of the lower limb, massive bleeding from the puncture site) occurring within 24 hours.
Measured: Up to 24 hours post-procedure
Rate of cardiac surgery related complications
Peri-procedural complications associated with cardiac surgery - bleeding requiring re-thoracotomy, cardiac tamponade
Measured: Up to 24 hours post-procedure
Rate of other major peri-procedural complications
Other major peri-procedural complications: acute renal failure, systemic infection, respiratory failure requiring prolonged ventilation (>24 hours).
Measured: Up to 7 days post-procedure
Rate of ipsilateral stroke in the first year
Occurence of any ipsilateral stroke
Measured: From 31 days till 365 days post-procedure
Rate of ipsilateral stroke up to 5 years
Occurence of any ipsilateral stroke
Measured: From 1 year till 5 years post-procedure
Rate of any stroke up to 5 years
Occurence of any stroke during registry follow up
Measured: Untill 5 years post-procedure
Stroke free survival rate up to 1 year
Survival without any stroke up to 1 year follow up
Measured: Untill 1 year post-procedure
Ipsilateral stroke free survival rate up to 1 year
Survival without ipsilateral stroke up to 1 year follow up
Measured: Untill 1 year post-procedure
Stroke free survival rate up to 5 years
Survival without any stroke up to 5 year follow up
Measured: Untill 5 year post-procedure
Ipsilateral stroke free survival rate up to 5 years
Survival without ipsilateral stroke up to 5 year follow up
Measured: Untill 5 year post-procedure
Rate of coronary or carotid restenosis
Clinical coronary or carotid restenosis requiring treatment
Measured: Untill 5 year post-procedure
Rate of cardiac or carotid reintervention
Clinically indicated carotid or cardiac reintervention during folow up period
Measured: Untill 5 year post-procedure
Ultrasound Evaluated Carotid Artery Velocities
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the internal carotid/common carotid artery assessed by ultrasound - after the procedure, then at 12 months after the procedure.
Measured: After procedure and at 12 months follow up
Recurrence of angina or valvular heart disease at 30 days and 12 months
Recurrence of angina or symptomatic valvular heart disease
Measured: At 30 days and 12 months after surgery
Recurrence of angina or valvular heart disease up to 5 years
Recurrence of angina or symptomatic valvular heart disease
Measured: Up to 5 years thereafter after surgery
Feasibility of combined treatment
Number of patients actually treated with combined treatment to the number of patients qualified for treatment (excluding deaths in-between)
Measured: At the procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Musialek, MD, DPhil, Principal investigator, Department of Cardiac and Vascular Diseases, John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973579
- Sponsor's protocol ID
- SIM-GUARD
- Acronym
- SIM-GUARD
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dzierwa K, Kedziora A, Tekieli L, Mazurek A, Musial R, Dobrowolska E, Stefaniak J, Pieniazek P, Paluszek P, Konstanty-Kalandyk J, Sobczynski R, Kapelak B, Kleczynski P, Brzychczy A, Kwiatkowski T, Trystula M, Piatek J, Musialek P. Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study. J Cardiovasc Surg (Torino). 2023 Dec;64(6):591-607. doi: 10.23736/S0021-9509.23.12896-5. Epub 2023 Dec 11.
PubMed 38078710
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIMultaneous Urgent Cardiac Surgery and Endovascular Stroke Prevention Using the Micronet-covered CGUARD Stent in Hemodynamically Compromised Patients at Increased Peri-operative Stroke Risk: SIM-GUARD Study
- ClinicalTrials.gov ID
- NCT04973579
- Acronym / sponsor ID
- SIM-GUARD / SIM-GUARD
- Conditions
- Carotid Stenosis, Coronary Artery Disease, Valvular Heart Disease, Myocardial Infarction, Pulmonary Edema With Heart Failure
- Keywords
- Carotid Stenosis, Coronary Artery Disease, Valvular Disease, Heart Failure, Pulmonary Edema, Single Anesthesia, Simultaneous Procedure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 22 Jul 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.
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and/or valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study.
Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.
Detailed description
The coexistence of symptomatic or unstable stroke-threatening carotid atherosclerotic stenosis with cardiac disease requiring urgent / fast-track cardiac surgery (such as advanced unstable or multivessel coronary artery disease, recent myocardial infarction or pulmonary edema, severely impaired myocardial contractility, and/or severe valvular disease requiring surgical treatment) represents a major medical and therapeutic/logistics challenge.
According to current guidelines, in absence of prospective randomized evidence, the most appropriate management strategy for a given patient should be determined by a multispecialty team. In hemodynamically compromised patients sequential treatment (i.e., first carotid stenosis repair followed by surgery or first cardiac surgery followed by carotid stenosis treatment, either surgical or endovascular) is associated with a high risk of cardiac complications in case of first-stage carotid stenosis treatment and a high risk of neurological complications in case of the first-stage cardiac surgery.
In this challenging patient group, we have introduced single-stage, truly simultaneous procedure. The fundament of the strategy is to establish extracorporeal circulation back-up ("CEC standby") prior to the minimally invasive (endovascular) treatment of stroke-threatening carotid artery stenosis in the hybrid room under single anesthesia.
For CAS (proximal or distal protected), in case of suboptimal femoral access (or lack of femoral access), a direct access via carotid artery is used (transcervical or transcarotid revascularization), this is immediately followed by cardiac surgery.
The procedure, each time, follows recommendation of the Multispecialty Team (Heart Team + NeuroVascular Team) as the lowest-deemed risk management in patients with indications for both urgent both carotid revascularization and cardiac surgery. Both carotid and cardiac treatment are performed under single anesthesia with the feasibility of immediate extracorporeal circulation support during carotid revascularization in case of hemodynamic collapse.
Eligibility for treatment is based on the decision (recommendation) of a multidisciplinary Heart Team along with a NeuroVascular Team consisting of a cardiac surgeon, cardiologist, anesthesiologist, angiologist, neurologist, and vascular surgeon, with the concomitant use of routine pharmacotherapy and non-pharmacological prevention - according to current guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous cardiac surgery and carotid stenting | – | Procedure: Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)Patients with Heart Team and NeuroVascular Team recommendation to perform simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) including proximal or distal neuroembolic protection and cardiac surgery (CABG or surgical valve replacement / repair procedure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers registry of patients with Heart and NeuroVascular Team recommendation for single-stage simultaneous surgical and endovascular procedure. The SIM-GUARD single arm registry design and exploratory nature precluded sample size calculation. The number of patients to be enrolled is selected based on the number of procedures at the Center and the average typical size of studies/registries in this field of interventional treatment.
Key inclusion criteria (8 listed)
- Patients eligible for concomitant carotid artery stenting in conjunction with cardiac surgery based on Heart Team and NeuroVascular Team reccomendation and according to local standards of practice.
- Signed informed consent form
- Consent to (routinely performed in this group of patients) follow-up visits and tests performed (routinely) during long-term follow-up
- De novo atherosclerotic lesions or neo-atherosclerosis.
- Symptomatic patients (with a history of ipsilateral transient cerebral ischemia, stroke or amaurosis fugax within the past 6 months) with carotid artery stenosis ≥50% as assessed by NASCET angiography or
Key exclusion criteria (13 listed)
- Expected survival time <1 year (e.g., cancer).
- Renal failure with GFR < 20 ml/min/1.73 m2 as calculated by the CKD-EPI formula
- Women who are pregnant (pregnancy test).
- Coagulopathies.
- History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy.
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 |
|---|---|---|
| Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)The registry enrolls patients qualified for treatment with the methods evaluated in the registry, using routinely applicable procedures and devices. In cardiac surgery - surgical treatment systems for advanced ischemic heart disease and/or valvular disease (including - mechanical/biologic heart valves - regulatory approved for routine use and typically used at the Facility. In the simultaneous treatment of stroke-threatening carotid artery atherosclerosis - temporary neuroprotection systems (proximal, distal, according to medical indications and local experience) - regulatory approved for routine use and typically used at the center (for over 20 years). CGuard anti-embolic mesh stent system - a self-expanding nitinol carotid stent wrapped in MicroNet, which prevents fragments of atherosclerotic plaque from entering the lumen of the carotid artery - approved for routine use and typically used at the Center (over 5 years). | Procedure or surgery | Simultaneous cardiac surgery and carotid stenting |
Primary outcome
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
Time frame: 30 days from index procedure
Freedom from any death, any stroke, and myocardial infarction at 30-day follow-up
21 secondary outcomes
Freedom from major clinical complications comprising MACNE at 6 months
Time frame: At 6 months from index procedure
Freedom from major clinical complications comprising MACNE at 12 months
Time frame: At 12 months from index procedure
Procedural success rate for carotid stenting
Time frame: Periprocedural
Technical success
Time frame: At the procedure completion
Clinical success
Time frame: Day 2 after procedure
Rate of arterial access complications
Time frame: Up to 24 hours post-procedure
Rate of cardiac surgery related complications
Time frame: Up to 24 hours post-procedure
Rate of other major peri-procedural complications
Time frame: Up to 7 days post-procedure
Rate of ipsilateral stroke in the first year
Time frame: From 31 days till 365 days post-procedure
Rate of ipsilateral stroke up to 5 years
Time frame: From 1 year till 5 years post-procedure
Rate of any stroke up to 5 years
Time frame: Untill 5 years post-procedure
Stroke free survival rate up to 1 year
Time frame: Untill 1 year post-procedure
Ipsilateral stroke free survival rate up to 1 year
Time frame: Untill 1 year post-procedure
Stroke free survival rate up to 5 years
Time frame: Untill 5 year post-procedure
Ipsilateral stroke free survival rate up to 5 years
Time frame: Untill 5 year post-procedure
Rate of coronary or carotid restenosis
Time frame: Untill 5 year post-procedure
Rate of cardiac or carotid reintervention
Time frame: Untill 5 year post-procedure
Ultrasound Evaluated Carotid Artery Velocities
Time frame: After procedure and at 12 months follow up
Recurrence of angina or valvular heart disease at 30 days and 12 months
Time frame: At 30 days and 12 months after surgery
Recurrence of angina or valvular heart disease up to 5 years
Time frame: Up to 5 years thereafter after surgery
Feasibility of combined treatment
Time frame: At the procedure completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 38078710Dzierwa K, Kedziora A, Tekieli L, Mazurek A, Musial R, Dobrowolska E, Stefaniak J, Pieniazek P, Paluszek P, Konstanty-Kalandyk J, Sobczynski R, Kapelak B, Kleczynski P, Brzychczy A, Kwiatkowski T, Trystula M, Piatek J, Musialek P. Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study. J Cardiovasc Surg (Torino). 2023 Dec;64(6):591-607. doi: 10.23736/S0021-9509.23.12896-5. Epub 2023 Dec 11.
- 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.
Piotr Musialek, MD, DPhil principal investigator
Department of Cardiac and Vascular Diseases, John Paul II Hospital
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 Carotid Stenosis and Coronary Artery Disease, run by John Paul II Hospital, Krakow at 1 site in Poland.
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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 22 Jul 2021. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Musialek, MD, DPhil (+48126142287, pmusialek@szpitaljp2.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days (time frame: 30 days from index procedure). 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 NCT04973579, which also lists 1 linked publication.
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 22 Jul 2021.