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

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ClinicalTrials.gov Identifier: NCT02750644
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Joaquin de Haro, M.D., Hospital Universitario Getafe

Tracking Information
First Submitted Date April 18, 2016
First Posted Date April 25, 2016
Last Update Posted Date April 25, 2016
Study Start Date January 2005
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2016)
all major adverse events [ Time Frame: through 30-day follow-up or thereafter up to 4 years ]
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Postapproval Trial On Carotid Stenting in Patients With High Risk Vs Standard Risk for Open Carotid Endarterectomy(REAL)
Official Title Post Approval Non-randomized Double-arm Prospective Open Label Follow-up Trial on Carotid Stenting Using MOMA Proximal Embolic Cerebral Protection Device in Patients With High Risk vs Standard Risk for Open Carotid Endarterectomy(REALTrial)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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%.
Condition Carotid Artery Diseases
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 21, 2016)
125
Original Actual Enrollment Same as current
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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 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%

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02750644
Other Study ID Numbers REAL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Joaquin de Haro, M.D., Hospital Universitario Getafe
Study Sponsor Joaquin de Haro, M.D.
Collaborators Not Provided
Investigators
Principal Investigator: Joaquin De Haro, MD Hospital Universitario Getafe
PRS Account Hospital Universitario Getafe
Verification Date April 2016