Postapproval Trial On Carotid Stenting in Patients With High Risk Vs Standard Risk for Open Carotid Endarterectomy(REAL)

NCT02750644 | Completed

• 1 other identifier: REAL
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

Until the irruption of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), carotid stenting (CAS) has been mainly offered to those patients considered at "high risk" for open carotid endarterectomy (CEA) based on the available data from large randomized clinical trials. "High risk" has been defined as (1) patients with severe comorbidity (class III/IV congestive heart failure, class III/IV angina, coronary disease involving ≥ 2 major vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary disease, severe renal failure) and (2) Technical/challenging anatomical criteria (previous neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy restenosis, inaccessible lesions or tracheotomy). Several recent studies have called medical "high-risk" into question for CAS indication. The purpose of this study is to evaluate the safety and perioperative and long-term effectiveness in patients with significant carotid artery stenosis with "high-risk" criteria (for CEA) treated with carotid stenting and proximal protection device (MOMA®) compared to patients with standard-surgical-risk features.

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• all major adverse events

  the composite rate of all major adverse events (MAE), including death, stroke, and Myocardial Infarction, through 30-day follow-up or thereafter up to 4 years

  through 30-day follow-up or thereafter up to 4 years

Study Arms (2)

High-risk

Patients with atherosclerotic carotid disease with (1) severe comorbidity (class III/IV congestive heart failure, class III/IV angina, coronary disease involving ≥ 2 major vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary disease, severe renal failure) and (2) Technical/challenging anatomical criteria (previous neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy restenosis, inaccessible lesions or tracheotomy).

Standard-risk

Patients with atherosclerotic carotid disease without (1) severe comorbidity (class III/IV congestive heart failure, class III/IV angina, coronary disease involving ≥ 2 major vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary disease, severe renal failure) and (2) Technical/challenging anatomical criteria (previous neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy restenosis, inaccessible lesions or tracheotomy).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Internal carotid stenosis symptomatic patients who have a transient ischemic attack, amaurosis fugax, or minor nondisabling stroke in the distribution of the study artery within 180 days of inclusion and have been shown carotid artery stenosis ≥50% by angiography, ≥70% by ultrasound, or ≥70% by CT angiography or magnetic resonance (MR) angiography if ultrasound is 50% to 69%. Asymptomatic patients who have carotid artery stenosis of ≥60% by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if ultrasound is 50% to 69%.

You may qualify if:

• Asymptomatic patients who have carotid artery stenosis of ≥60% by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if ultrasound is 50% to 69%

You may not qualify if:

• Patient is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand
• Patient has an myocardial infarction within 72 hours prior to carotid stenting
• Patient has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥ 15 or Rankin \>3) at pre-procedure neurological exam
• Patient had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to index procedure
• Patient had a stroke or retinal artery occlusion within 1 month prior to index procedure
• Patient has severe chronic renal failure (creatinine \> 2.5mg/dL)
• The target carotid artery is completely occluded
• The common carotid artery ostium has stenosis that required treatment
• The presence of ipsilateral intracranial stenosis that requires treatment
• The inability to position a stiff 0.035" guidewire in the external carotid artery
• Contralateral occlusion of internal carotid artery and vertebral arteries

Sponsors & Collaborators

• Joaquin de Haro, M.D.: lead

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joaquin De Haro, MD

  Hospital Universitario Getafe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Joaquin de Haro, M.D., Vascular Research Unit Principal Investigator

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 25, 2016
• Study Start: January 1, 2005
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 25, 2016

Record last verified: 2016-04