Clinical Trials

C-Guardians
  • Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (C-Guardians)
  • A Multicenter, Single-Arm, Pivotal Study
  • Evaluating Safety and Efficacy of CGuard™ Carotid Stent System
  • Treating Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing CAS
  • Study for a U.S. FDA-regulated Device Product
  • Study Start Date: July 1, 2021
  • PI: Chris Metzger, MD Ballad Health, USA   
  • PI: Piotr Musialek, MD DPhil John Paul II Hospital, Krakow, Poland
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)
  • Publication
  • 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
  • Publication @ 12 months (substitute Summary)
CASANA
  • CGuard™
  • PI: Renato Casana
  • 82 consecutive patients
  • A single centre study
  • Follow up: 30-day results
  • Publication (substitute Summary)
WISSGOTT
  • CGuard™
  • PI: Christian Wissgott and Reimer Andresen
  • 30 Consecutive patients
  • Prospective single-center study
  • Follow up: 6 months
  • Publication (substitute Summary)
WISSGOTT One size- fits-all
  • CGuard™
  • PI: Christian Wissgott
  • 30 Consecutive patients
  • Prospective, single-center study
  • Follow up: 6 months
  • Publication (substitute Summary)
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
  • Publication (substitute Summary) @ 30 days
  • Publication (substitute Summary) @ 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
  • Publication @ 30 days
  • Publication @ 12 months (link to https://www.jacc.org/doi/pdf/10.1016/j.jcin.2021.05.045)
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.
  • Publication @ 30 days
  • Publication @ 12 months
  • 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