InspireMD

Layers of Evidence

Stroke prevention with CGuard® has been proven in numerous trials and case studies worldwide
C-GUARDIANS U.S. Investigational Device Exemption (IDE) trial – 1-year follow-up
316
Patients
24
Trial Sites
🇺🇸 🌎
U.S. and Europe
Low rates of major adverse events
Intent-to-treat (ITT)
0.95%
through 30 days
Death, any Stroke, or Myocardial Infarction (DSMI)
1.93%
through 1 year
DSMI through 30 days plus ipsilateral stroke through 1 year
Per protocol (PP)
0.63%
through 30 days
Death, any Stroke, or MI (DSMI)
1.71%
through 1 year
DSMI through 30 days plus ipsilateral stroke through 1 year
The lowest independently adjudicated 30-day and 1-year primary endpoint major adverse event rates of any pivotal study of carotid intervention1-10

Clinical Trials

C-GUARDIANS 30-day Outcomes

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (C-GUARDIANS)

Objective: 30-day assessment of the safety and efficacy of the CGuard™ carotid stent system in patients (N=316) at high risk for carotid endarterectomy with  carotid artery stenosis (25% symptomatic).

Conclusion: Treatment with the CGuard™ carotid stent system with embolic protection had a low incidence of stroke, death, or MI post-procedure to 30-day follow-up.

NIH Trial Summary VIVA23 Conference Presentation

PARADIGM-EXTEND

Accumulating long-term evidence for MicroNetTM-covered stent safety, efficacy, and durability in primary and secondary stroke prevention: 5-year data from the PARADIGM-Extend prospective academic trial

Objective: To evaluate the feasibility and outcome of routine anti-embolic stent system use in unselected, consecutive patients referred for carotid revascularization (all-comers study).

Conclusion: Long-term clinical and duplex ultrasound evidence is consistent with normal healing and sustained safety and stroke prevention efficacy of the MicroNetTM-covered embolic prevention stent system, which is routinely used, on top of optimized medical therapy, for stroke prevention in symptomatic and increased-stroke-risk asymptomatic subjects with carotid stenosis recommended for revascularization by the NeuroVascular Team.

5yr Publication LINC Conference Presentation

Randomized Controlled Trial

Randomized Controlled Trial of Conventional Versus MicroNetTM-Covered Stent in Carotid Artery Revascularization

Objective: The aim of this study was to compare procedure-related ipsilateral cerebral embolism with a conventional (Acculink, Abbott Vascular) versus a MicroNetTM-covered (CGuardTM, InspireMD) stent in carotid artery stenting (CAS).

Conclusion: The MicroNetTM-covered stent significantly reduced periprocedural and abolished postprocedural cerebral embolism compared to a conventional carotid stent. This is consistent with the MicroNetTM-covered stent’s sustained embolism prevention, which translates into cerebral protection during and after CAS. The present findings may influence decision-making in carotid revascularization.

30-day Publication 1yr Publication
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Case Studies

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Protected Carotid Artery Stenting with MicroNet™ Carotid Stent Incathlab Case of the month: Nov 22

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Severe Carotid Plaque Treated with CGuard™ EPS, Prof. Cremonesi

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Ulcerated Carotid Stenosis treated with CGuard™, Prof. Musialek

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Publications

Zidan M, Gronemann C, Lehnen NC, et al. Stenting with dual-layer CGuard stent in acute sub-occlusive carotid artery stenosis and in tandem occlusions: a monocentric study

Neuroradiology. 2024;66(9):1635-1644.

Trystula M, Herzeele IV, Kolvenbach R, et al. Next-Generation TransCarotid Artery Revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes – TOPGUARD Study

Cardiovasc Surg (Torino). 2024;65(3):181-194.
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Clinical Presentations

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References:
  1. InspireMD, Inc. C-GUARDIANS Pivotal Trial: Primary Endpoint Clinical Study Report. Version F (Protocol PRO-9017).
  2. Yadav JS, et al. N Engl J Med. 2004 Oct;351(15):1493-1501. doi: 10.1056/ NEJMoa040127.
  3. Matsumura JS, et al. J Vasc Surg. 2012 Apr;55(4):968-76. doi: 10.1016/j.jvs.2011.10.120.
  4. Higashida R, et al. Stroke vol. 41,2 (2010): e102-9. doi: 10.1161/STROKEAHA.109.564161.
  5. Brott TG, et al. N Engl J Med. 2010 Jul;363(1):11-23. doi: 10.1056/NEJMoa0912321. Epub 2010 May 26.
  6. Kwolek CJ, et al. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460.
  7. U.S. Food and Drug Administration. Summary of safety and effectiveness data (SSED): Roadsaver/CASPER Carotid Stent System (PMA P210030). Published November 20, 2024
  8. Gray WA, et al. J Am Coll Cardiol Intv. 2025 Feb;18(3):367-76. doi: 10.1016/j.jcin.2024.10.031.
  9. Safian RD, et al. J Am Coll Cardiol. 2006 Jun;47(12):2384-89. doi: 10.1016/j.jacc.2005.12.076.
  10. Langhoff R, et al. Cardiovasc Intervent Radiol. 2025 Mar;Vol 48 427–37. doi: 10.1007/s00270-025-04003-z.
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