A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke:
Lukasz Tekieli1,2,3, Andrej Afanasjev4, Maciej Mazgaj5
1St. John Paul II Hospital in Krakow Stroke Thrombectomy-Capable Cardiovascular Centre, Krakow, Poland.
Insights
The MicroNET-covered carotid stent demonstrated high success and 90-day patency in acute carotid-related stroke patients. This study highlights favorable outcomes with the CGuard stent in emergency recanalization procedures.
Area of Science:
- Interventional Neurology
- Vascular Surgery
- Neurocritical Care
Background:
- Acute carotid-related stroke (CRS) presents significant challenges due to high thrombo-embolic load and brain tissue involvement.
- First-generation single-layer carotid stents have limitations, including failure to insulate athero-thrombotic material, increasing thrombosis risk and a 20-30% risk of new cerebral embolism.
Purpose of the Study:
- To evaluate the outcomes of the MicroNET-covered carotid stent (CGuard) in consecutive CRS patients undergoing emergency recanalization.
- This multi-center, multi-specialty study assessed the safety and efficacy of the CGuard stent in a real-world setting.
Main Methods:
- Seventy-five eligible CRS patients were enrolled across 7 interventional stroke centers.
- The study utilized the MicroNET-covered stent (cell area ≈ 0.02-0.03 mm²) in all cases, with treatment strategies varying by center/operator.
- Key outcome measures included technical success, modified Thrombolysis in Cerebral Infarction (mTICI) scores, symptomatic intracranial hemorrhage, mortality, and 90-day modified Rankin Scale (mRS) scores.
Main Results:
- Technical success was 100%, with 89% of patients achieving final mTICI 2b-c/3 reperfusion.
- The in-hospital and 90-day mortality rates were 9.4% and 12.2%, respectively.
- Ninety-day stent patency was 93.2%, with factors like small balloon diameter or absent post-dilatation predicting patency loss.
Conclusions:
- The MicroNET-covered stent demonstrated a high acute angiographic success rate and favorable 90-day clinical outcomes in this cohort of CRS patients.
- Despite procedural variability, the CGuard stent proved effective in emergency recanalization, offering a promising option for managing acute carotid-related stroke.
Introduction:
Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism.
Aim:
To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm2) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine.
Material And Methods:
Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers.
Results:
The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001).
Conclusions:
This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).
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