Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients

NCT04973579 | Recruiting

• 1 other identifier: SIM-GUARD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  30 days from index procedure

Secondary Outcomes (21)

• Freedom from major clinical complications comprising MACNE at 6 months

  At 6 months from index procedure

• Freedom from major clinical complications comprising MACNE at 12 months

  At 12 months from index procedure

• Procedural success rate for carotid stenting

  Periprocedural

• Technical success

  At the procedure completion

• Clinical success

  Day 2 after procedure

Study Arms (1)

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)

Procedure: Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)

Interventions

Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure) 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).

Simultaneous cardiac surgery and carotid stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (1)

Department of Cardiac and Vascular Diseases, John Paul II Hospital

Krakow, 31-202, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 38078710 DERIVED

MeSH Terms

Conditions

Carotid Stenosis; Coronary Artery Disease; Heart Valve Diseases; Myocardial Infarction; Heart Failure; Pulmonary Edema

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Piotr Musialek, MD, DPhil

  Department of Cardiac and Vascular Diseases, John Paul II Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, DPhil

CONTACT

+48126142287; pmusialek@szpitaljp2.krakow.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

PL (1)