Carotid Occlusion IntoleranceNCT01922609
Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.
An observational study of Carotid Occlusion Intolerance, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
The aim of this observational pilot study is to determine whether intolerance of carotid occlusion during carotid artery stenting can be predicted with preprocedural transcranial Doppler evaluation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carotid Occlusion Intolerance
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- May 2013to Aug 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with carotid artery stenosis indicated for carotid artery stenting with the use of proximal flow arrest protection device.
Who may be able to join
- Either >50% symptomatic carotid artery stenosis (transient ischemic attack or ischemic stroke within 6 months before procedure) or >70% asymptomatic carotid artery stenosis eligible for carotid artery stenting with proximal flow arrest protection
- Signed informed consent
Who cannot join
- Disagreement to be included in the study
- Inadequate acoustic window for transcranial Doppler ultrasound monitoring
- Carotid occlusion
- Significant extracranial artery stenosis (>50%) other than target artery
- Inability to hold breath for sufficient time (approximately 30s)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Department of Cardiology, University Hospital Motol
Prague, Czech Republic, 15006
Miloslav Spacek, MD, 0042022443 ext. 4901, mildaspacek@gmail.com
About this study
The aim of this observational pilot study is to determine whether intolerance of carotid occlusion during carotid artery stenting can be predicted with preprocedural transcranial Doppler evaluation.
Read the detailed description
Carotid artery stenting procedures are increasingly performed with devices that involve endovascular clamping of the common carotid artery, thus exposing the ipsilateral hemisphere to hypoperfusion. Approximately 5% of patients do not tolerate the clamp and are in increased risk of periprocedural cerebrovascular complication such as transient ischemic attack or stroke. To date, there is no method available that could be used to predict the risk of occlusion intolerance. The aim of this study is to determine whether preprocedural evaluation with transcranial Doppler ultrasonography can be effective in prediction of occlusion intolerance.
- Conditions
- Carotid Occlusion Intolerance
- Keywords
- Carotid stenting, Proximal protection system, Transcranial Doppler ultrasound, Cerebrovascular reserve
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 |
|---|---|---|
| Normal cerebrovascular reserve | Patients without preprocedural TCD signs of impaired cerebrovascular reserve | |
| Impaired cerebrovascular reserve | Patients with preprocedural TCD signs of impaired cerebrovascular reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid occlusion intolerance
Intolerance of carotid occlusion during carotid artery stenting detected by means of transcranial Doppler evaluation or by clinical signs of occlusion intolerance.
Measured: During carotid stenting procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Occlusion IntoleranceStudies 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miloslav Spacek, MD, University Hospital, Motol
- Investigators
- Miloslav Spacek, MD, Principal investigator, Department of cardiology, University Hospital MotolJosef Veselka, MD, PhD, Study chair, Department of cardiology, University Hospital Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922609
- Sponsor's protocol ID
- EK-1075/13
- Status last verified
- Aug 2013
- First submitted
- 11 Aug 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.
- ClinicalTrials.gov ID
- NCT01922609
- Acronym / sponsor ID
- EK-1075/13
- Conditions
- Carotid Occlusion Intolerance
- Keywords
- Carotid stenting, Proximal protection system, Transcranial Doppler ultrasound, Cerebrovascular reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 14 Aug 2013 (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.
The aim of this observational pilot study is to determine whether intolerance of carotid occlusion during carotid artery stenting can be predicted with preprocedural transcranial Doppler evaluation.
Detailed description
Carotid artery stenting procedures are increasingly performed with devices that involve endovascular clamping of the common carotid artery, thus exposing the ipsilateral hemisphere to hypoperfusion. Approximately 5% of patients do not tolerate the clamp and are in increased risk of periprocedural cerebrovascular complication such as transient ischemic attack or stroke. To date, there is no method available that could be used to predict the risk of occlusion intolerance. The aim of this study is to determine whether preprocedural evaluation with transcranial Doppler ultrasonography can be effective in prediction of occlusion intolerance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal cerebrovascular reserve | – | –Patients without preprocedural TCD signs of impaired cerebrovascular reserve |
| Impaired cerebrovascular reserve | – | –Patients with preprocedural TCD signs of impaired cerebrovascular reserve |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with carotid artery stenosis indicated for carotid artery stenting with the use of proximal flow arrest protection device.
Key inclusion criteria (2 listed)
- Either >50% symptomatic carotid artery stenosis (transient ischemic attack or ischemic stroke within 6 months before procedure) or >70% asymptomatic carotid artery stenosis eligible for carotid artery stenting with proximal flow arrest protection
- Signed informed consent
Key exclusion criteria (5 listed)
- Disagreement to be included in the study
- Inadequate acoustic window for transcranial Doppler ultrasound monitoring
- Carotid occlusion
- Significant extracranial artery stenosis (>50%) other than target artery
- Inability to hold breath for sufficient time (approximately 30s)
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
Carotid occlusion intolerance
Time frame: During carotid stenting procedure
Intolerance of carotid occlusion during carotid artery stenting detected by means of transcranial Doppler evaluation or by clinical signs of occlusion intolerance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
Related trials for Carotid Occlusion Intolerance
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
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.
Department of Cardiology, University Hospital Motol
Prague, Czechia
Miloslav Spacek, MD principal investigator
Department of cardiology, University Hospital Motol
Josef Veselka, MD, PhD study chair
Department of cardiology, University Hospital Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Occlusion Intolerance, run by University Hospital, Motol at 1 site in Czechia.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid occlusion intolerance (time frame: During carotid stenting procedure). 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 14 Aug 2013.