Comparing Carotid Stenting With Endarterectomy in Severe Asymptomatic Carotid Stenosis

NCT00772278 | Completed Phase 4 DMC

• 2 other identifiers: CMC-07-0094-CTILcas vs cea-001-carmel
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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
• morbidity at the site of incision (infection or local hematoma)
• damage to cranial nerves (hypoglossus, vagus)
• brain hyperperfusion which is defined as severe headache which is not responsive to analgesics with or without nausea and vomiting.
• 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

Keywords

carotid stenosis; asymptomatic; carotid stenting; carotid endarterectomy

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (7)

• incision site morbidity

  2 years

• cranial nerves damage

  2 years

• brain hyperperfusion

  2 years

• bradycardia within the first 24 hours

  2 years

• microembolic brain events

  2 years

Study Arms (2)

CAS

ACTIVE COMPARATOR

carotid artery stenting

Procedure: carotid artery stenting

CEA

ACTIVE COMPARATOR

carotid endarterectomy

Procedure: carotid endarterectomy

Interventions

carotid artery stenting PROCEDURE

carotid artery angiography, angioplasty and stenting

Also known as: carotid stent - precise - rapid exchange® (Cordis, FL, USA), carotid artery filter - angioguard® (Cordis, FL, USA)

CAS

carotid endarterectomy PROCEDURE

open surgery including endarterectomy

CEA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stenosis of 70% or more by carotid artery duplex, CTA or MRA.
• No evidence of TIA or CVA originating in area of the brain supplied by the carotid artery under study, in the four months preceding treatment.
• Eligibility for both treatment options:
• suited for operative treatment as assessed by an anesthesiologist
• suited for endovascular procedure by established radiological guidelines (including: access to the stenotic area via the vessels of the aortic arch, the absence of occlusion preventing this access, absence of significant atherosclerosis within the arch of aorta, absence of torturous anatomy of the common and internal carotid artery, and absence of thrombus in the area of stenosis)

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Dallit Mannheim, Dr.

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: October 15, 2008
• Study Start: January 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

IL (1)