Related Experiment Video
Updated: Dec 10, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study
Pasqualino Sirignano1, Eugenio Stabile2, Wassim Mansour1
1Vascular and Endovascular Surgery Unit, Department of Surgery Paride Stefanini, Sapienza University of Rome, Rome, Italy.
Insights
The CGuard embolic prevention system demonstrates safety and efficacy in carotid artery stenting (CAS). This dual-layer mesh-covered stent system showed a low rate of adverse neurological events in a large clinical registry.
Area of Science:
- Vascular surgery
- Interventional cardiology
- Medical device technology
Background:
- Carotid artery stenting (CAS) carries a risk of neurologic events due to debris dislodgement.
- Dual-layer mesh-covered stents aim to improve plaque coverage and reduce embolic events during CAS.
- The CGuard embolic prevention system is a novel dual-layer mesh-covered stent designed for enhanced safety in CAS.
Purpose of the Study:
- To evaluate the 30-day safety and efficacy of the CGuard embolic prevention system in clinical practice.
- To assess the incidence of stroke, transient ischemic attack (TIA), acute myocardial infarction (AMI), and death following CAS with the CGuard system.
- To determine the technical and procedural success rates of CAS using this dual-layer mesh-covered stent.
Main Methods:
- A prospective, multispecialty registry included 733 consecutive patients undergoing CAS with the CGuard system.
- The study evaluated primary endpoint of stroke up to 30 days post-procedure.
- Secondary endpoints included procedural success, technical success, external carotid artery occlusion, TIA, AMI, and mortality rates.
Main Results:
- Procedural success was 100%, with technical success in 99.86% of patients.
- The cumulative stroke rate was 0.54% within 30 days.
- In-hospital and 30-day adverse events included TIAs (0.82%), minor strokes (0.27%), AMIs (0.41%), and mortality (0.14%).
Conclusions:
- The CGuard embolic prevention system is safe for clinical use in carotid artery stenting.
- This dual-layer mesh-covered stent is associated with a low occurrence of adverse neurological events.
- Real-world data supports the use of the CGuard system for reducing embolic complications in CAS.
Objectives:
This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice.
Background:
When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems.
Methods:
From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates.
Results:
Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%.
Conclusions:
This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.
