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Comparing Carotid Stenting With Endarterectomy in Severe Asymptomatic Carotid Stenosis

NCT00772278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2017-07-25

No results posted yet for this study

Summary

Purpose of this study:

Primary:

• Comparison of cardiovascular mortality and morbidity which includes cardiac and neurological morbidity (TIA and CVA) in the two invasive treatments of asymptomatic carotid artery stenosis

Secondary:

* Comparison of non cardiovascular morbidity caused by the two invasive techniques

1. morbidity at the site of incision (infection or local hematoma)
2. damage to cranial nerves (hypoglossus, vagus)
3. brain hyperperfusion which is defined as severe headache which is not responsive to analgesics with or without nausea and vomiting.
4. events of bradycardia within the first 24 hours, clinically evident and/or silent
* microembolic brain events immediately after the procedure and their relationship with morbidity and/or mortality due to TIA's or CVA's
* the change in the stenotic carotid artery at the time of follow up with duplex of neck arteries
* the comparison of the affect of the two procedures on patient life style

Conditions

  • Carotid Stenosis

Interventions

PROCEDURE

carotid artery stenting

carotid artery angiography, angioplasty and stenting

PROCEDURE

carotid endarterectomy

open surgery including endarterectomy

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Principal Investigators

  • Dallit Mannheim, Dr. · Carmel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Israel

Study Locations

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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 NCT00772278 on ClinicalTrials.gov