Highly-calcific carotid lesions endovascular management in symptomatic and increased-stroke-risk asymptomatic patients using the CGuard™ dual-layer carotid stent system: Analysis from the PARADIGM study
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Updated: Jan 26, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Adam Mazurek1, Lukasz Partyka2, Mariusz Trystula3
1Department of Cardiac & Vascular Diseases, John Paul II Hospital, Jagiellonian University Medical College, Krakow, Poland.
Insights
The CGuard™ stent is a feasible and safe option for treating highly calcific carotid stenosis (HCCS). This novel approach demonstrated good outcomes in patients undergoing carotid artery stenting (CAS).
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Highly calcific carotid stenosis (HCCS) presents significant challenges for conventional carotid artery stenting (CAS).
- The CGuard™ stent offers a dual-layer design with a high-radial-force open-cell frame and MicroNet sealing properties to address these challenges.
Purpose of the Study:
- To evaluate the feasibility, safety, and clinical outcomes of endovascular management for HCCS using CGuard™ stents.
- To assess the performance of CGuard™ stents in patients with HCCS compared to non-HCCS lesions.
Main Methods:
- The PARADIGM study prospectively enrolled patients undergoing carotid revascularization.
- Lesions were categorized as HCCS based on specific angiographic criteria including calcific segment length, thickness, circularity, and severity grade (CCSS).
- Reproducibility of the Carotid Calcification Severity Scoring (CCSS) system was assessed.
Main Results:
- 106 lesions in 101 patients were analyzed (16 HCCS, 90 non-HCCS).
- The CCSS evaluation demonstrated good inter- and intra-observer reproducibility.
- While HCCS lesions required higher postdilatation pressures, CGuard™ CAS was feasible and safe, with no contrast extravasation or clinical complications.
- Residual diameter stenosis was higher in HCCS (9%) compared to non-HCCS (3%).
- No adverse clinical events or abnormal in-stent velocities were observed at 30 days and 12 months for HCCS.
Conclusions:
- Endovascular management of HCCS with CGuard™ dual-layer carotid stents is feasible and safe.
- A novel, reproducible algorithm for grading carotid artery calcification severity was successfully applied.
- Further investigation with larger HCCS cohorts and extended follow-up is recommended.
Objectives:
To assess feasibility, safety, angiographic, and clinical outcome of highly-calcific carotid stenosis (HCCS) endovascular management using CGuard™ dual-layer carotid stents.
Background:
HCCS has been a challenge to carotid artery stenting (CAS) using conventional stents. CGuard combines a high-radial-force open-cell frame conformability with MicroNet sealing properties.
Methods:
The PARADIGM study is prospectively assessing routine CGuard use in all-comer carotid revascularization patients; the focus of the present analysis is HCCS versus non-HCCS lesions. Angiographic HCCS (core laboratory evaluation) required calcific segment length to lesion length ≥2/3, minimal calcification thickness ≥3 mm, circularity (≥3 quadrants), and calcification severity grade ≥3 (carotid calcification severity scoring system [CCSS]; G0-G4).
Results:
One hundred and one consecutive patients (51-86 years, 54.4% symptomatic; 106 lesions) received CAS (16 HCCS and 90 non-HCCS); eight others (two HCCS) were treated surgically. CCSS evaluation was reproducible, with weighted kappa (95% CI) of 0.73 (0.58-0.88) and 0.83 (0.71-0.94) for inter- and intra-observer reproducibility respectively. HCCS postdilatation pressures were higher than those in non-HCCS; 22 (20-24) versus 20 (18-24) atm, p = .028; median (Q1-Q3). Angiography-optimized HCCS-CAS was feasible and free of contrast extravasation or clinical complications. Overall residual diameter stenosis was single-digit but it was higher in HCCS; 9 (4-17) versus 3 (1-7) %, p = .002. At 30 days and 12 months HCCS in-stent velocities were normal and there were no adverse clinical events.
Conclusion:
CGuard HCCS endovascular management was feasible and safe. A novel algorithm to grade carotid artery calcification severity was reproducible and applicable in clinical study setting. Larger HCCS series and longer-term follow-up are warranted.
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