Health TrialsbyHealthPanel

CGUARDIANS III IDE Pivotal Trial

ConditionCarotid Artery Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-82
SponsorInspireMD

About this trial

This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery Revascularization procedures using the CGuard Prime Carotid Stent System 80 in the treatment of carotid artery stenosis in patients at high risk for complications from CEA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

Disqualifiers

Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure

Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure

Vascular anatomy that would preclude safe sheath insertion or deliverability of stent

Previously placed stent in the ipsilateral ICA or CCA

Trial design

Design model

Single group

Treatments tested in this trial

  • SwitchGuardTM NPS

    Device

    The CGuard Prime™ 80 will be used in conjunction with the SwitchGuard™ NPS for the carotid artery stenting implantation procedure that will be performed by physician investigators experienced with transcarotid artery revascularization.

Treatment groups

103 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite primary endpoint

Incidence of the composite primary endpoint comprised of Death (all-cause mortality), all Stroke, or Myocardial Infarction (DSMI) through 30-days post-index procedure, based on Clinical Events Committee (CEC) adjudication.

Time frame
30 days

Secondary outcomes

1

Rate of all death within 30 days of the procedure

Time frame
30 days
2

Rate of cardiac death within 30 days of the index procedure

Time frame
30 days
3

Rate of neurological death within 30 days of the index procedure

Time frame
30 days
4

Rate of all strokes within 30 days of the procedure

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InspireMD

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: