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Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study

NCT02629653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-12-14

No results posted yet for this study

Summary

Aim of the study is to determine whether endovascular systemic cooling to a target temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy (CEA), is feasible and safe

Conditions

  • Carotid Artery Diseases
  • Hypothermia
  • Stroke
  • Carotid Artery Plaque
  • Carotid Artery Stenosis
  • Cerebrovascular Accident

Interventions

DEVICE

endovascular cooling (Zoll system)

The Zoll IVTM is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, and an ICY catheter (either IC-3585 AE or IC-3585).

Sponsors & Collaborators

  • S. Andrea Hospital

    lead OTHER

Principal Investigators

  • Francesco Orzi, Prof, MD · NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02629653 on ClinicalTrials.gov