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Cannula

CardioGard Cannula for Stroke

N/A
Waitlist Available
Led By Annetine C Gelijns, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

Eligible Conditions
  • Stroke
  • Aortic Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
Secondary outcome measures
Barthel Index <= 80
Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
+17 more

Trial Design

3Treatment groups
Active Control
Group I: CardioGard CannulaActive Control1 Intervention
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
Group II: Embol-X Embolic Protection DeviceActive Control1 Intervention
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Group III: Standard CannulaActive Control1 Intervention
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,489 Total Patients Enrolled
85 Trials studying Stroke
537,122 Patients Enrolled for Stroke
Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
526,889 Total Patients Enrolled
13 Trials studying Stroke
6,871 Patients Enrolled for Stroke
Annetine C Gelijns, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
3,840 Total Patients Enrolled
1 Trials studying Stroke
3,200 Patients Enrolled for Stroke
~37 spots leftby Jun 2025
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