- Study for U.S. FDA-regulated Device Product
- Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
- PI: Chris Metzger, MD, Ballad Health, USA
- Co-PI: Piotr Musialek, MD DPhil, John Paul II Hospital, Krakow, Poland
- Multicenter, single-arm, pivotal Study
- Study enrollment Period: July, 2021 to June, 2023 (23 months)
Clinical Trials
C-Guardians
CARENET
- CGuardTM
- PI: Joachim Schofer; Co-PI: Piotr Musialek
- 30 carotid artery stenting patients
- Prospective, multi-center, international, open label, single arm, non-randomized
- Primary endpoint: 30 day MACE (death, stroke, MI)
- Follow up: 30 Days and 5 years
PARADIGM 101
- CGuard™
- PI: Piotr Musialek
- 101 all comers, symptomatic and high-risk asymptomatic patients
- A prospective, all-referral-study
- Follow up: 0-1 month, 1-12 months
CASANA
- CGuard™
- PI: Renato Casana
- 82 consecutive patients
- A single centre study
- Follow up: 30-day results
WISSGOTT
- CGuard™
- PI: Christian Wissgott and Reimer Andresen
- 30 Consecutive patients
- Prospective single-center study
- Follow up: 6 months
WISSGOTT One size- fits-all
- CGuard™
- PI: Christian Wissgott
- 30 Consecutive patients
- Prospective, single-center study
- Follow up: 6 months
IRON-GUARD 1
- CGuard™
- PI: Carlo Setacci and Francesco Speziale
- 200 patients in 12 centers
- Physician-initiated prospective multicenter study
- Follow up: 30 days and 12 months
IRON-GUARD 2
- CGuard™
- PI: Francesco Speziale
- A Real life Registry, Physician-initiated prospective multicenter study
- 733 patients in 20 enrolling centers
- Follow up: 30 days, 12 months
PARADIGM-EXTEND
- CGuard™
- PI: Piotr Musialek
- A prospective, all-referral-study
- 428 (from 550 expected) all comers, high risk patients
- Follow up: 0-1 month, 1-12 months, 12-24 months, 24-36 months, 48-60 months
RANDOMIZED CONTROLLED TRIAL
- Prospective 1:1 randomized controlled study (designed and executed to obtain level 1 evidence), Independent Investigator Initiated Study, single center, randomized comparison of two interventional arms.
- 100 consecutives unselected (50 Acculink™ and 50 CGuard™) patients subjected to neuroprotected CAS (Emboshield™ distal protection – Abbott).
- Clinical follow up: post-procedural, 24-48 hours, 30 days and 12 months and 3-Year
- 100 consecutives unselected (50 Acculink™ and 50 CGuard™)
- Patients subjected to neuroprotected CAS (Emboshield™ distal protection – Abbott)
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CGuard™ EPS:
Carotid Embolic Prevention System
