Carotid Artery DiseasesREALNCT02750644
Postapproval Trial On Carotid Stenting in Patients With High Risk Vs Standard Risk for Open Carotid Endarterectomy(REAL)
An observational study of Carotid Artery Diseases, run by Joaquin de Haro, M.D..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases
- Type of treatment
- Injection or infusion
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%.
Who may be able to join
- 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%
Who cannot join
- 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)
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- 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
About this study
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)
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
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through 30-day follow-up or thereafter up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJan 2005
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joaquin de Haro, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joaquin de Haro, M.D., Hospital Universitario Getafe
- Investigators
- Joaquin De Haro, MD, Principal investigator, Hospital Universitario Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750644
- Sponsor's protocol ID
- REAL
- Acronym
- REAL
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02750644
- Acronym / sponsor ID
- REAL / REAL
- Conditions
- Carotid Artery Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Joaquin de Haro, M.D.University, hospital or other
- Study start
- Jan 2005
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%.
Key inclusion criteria (2 listed)
- 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%
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquin De Haro, MD principal investigator
Hospital Universitario Getafe
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases, run by Joaquin de Haro, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all major adverse events (time frame: through 30-day follow-up or thereafter up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.