Carotid StenosisRECASNCT01994187
Revascularization of Extracranial Carotid Artery Stenosis
An observational study of Carotid Stenosis and Surgery, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Investigate the current situation of carotid stenosis therapy in China. Establish the data bank of carotid stenosis revascularization (CAS and CEA) in China ,in order to get best quality control of the therapy, as well as confirm the standard treatment for carotid stenosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carotid Stenosis, Surgery, Stroke
- What is being tested?
- Carotid endarterectomy and carotid angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 2,100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jun 2015
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: one group:1050 cases of endarterectomy; the other group:1050 cases of carotid artery stent; totally:2100 cases of ravascularization for carotid stenosis
Inclusion Criteria:all the consecutive cases of carotid stenosis which received CEA or/and CAS in central hospital during the study(upto 2015).
Exclusion Criteria:the cases of carotid stenosis which received CEA or/and CAS in other hospital(not enroll this study) will be exclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of neurosurgery, Xuanwu hospital
Beijing, 100053
Jiao Li qun, MD, 86-10-83198899 ext. 8836, jiaoliqun@gmail.com
About this study
Official title: the Clinic Registration Study of Carotid Stenosis Revascularization
Investigate the current situation of carotid stenosis therapy in China. Establish the data bank of carotid stenosis revascularization (CAS and CEA) in China ,in order to get best quality control of the therapy, as well as confirm the standard treatment for carotid stenosis.
Understand situation about the adverse events occurs after the revascularization (CAS and CEA), evaluate the health economics .
Read the detailed description
The carotid stenosis was one of the higher risk of the ischemia stroke in China.In the mean time ,more and more people accept revascularization because of carotid stenosis.NASCAT indicated that CEA is the "golden standard" of the therapy of the carotid stenosis.But in china , case the opposite,only little patient receive CEA,on the other hand , most patients received angioplasty.
Expected no less than 2100 cases within 2 years for the whole study. We choose 39 hospitals whose experienced in CAS or/and CEA spread all over the country as multiple centers for this clinic registration study. All cases inclusion must be continuously registration.
The subject choice:All registered patients must be signed informed consent to register for non intrusive research this study ,the researchers during the study period should be continuous registration in patients undergoing surgical treatment of carotid stenosis, to ensure that the selected participants reflect the target patient population.
Medical Center choice: This research for the study of the registration, therefore, when the choice, all the medical center will be based on market research data.
Primary endpoint or the main aim of this registration study is to observe the following details:
- The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
- The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
Secondary endpoint or the other aims of this registration study:
- Success rate of any procedure (CAS or CEA).
- postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
- To observe the rate of restenosis during follow-up.
- Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
- Changes of the patients with mRS NIHSS Barthel Index score.
- Postoperative patients with drug use.
- Patient survival after 12 months.
- Patients hospitalized cost during follow-up.
This study does not need to be random. The study is expected to begin in July 2013 in the first, participants in the group stage for two years, to the end of June 2015 into the group of patients after surgery, follow-up of at least 12 months after the last case the participants into groups and followed up for 12 months, is expected to be completed in June 2015.
- Conditions
- Carotid Stenosis, Surgery, Stroke
- Being tested
- Carotid endarterectomy, carotid angioplasty
- Keywords
- Carotid stenosis, Angioplasty, Carotid endarterectomy, Stroke
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomyProcedure or surgery
Also called conventional carotid endarterectomy, Eversion carotid endarterectomy
carotid angioplastyProcedure or surgery
Also called carotid angioplasty with stent
| Study group | Role | What they receive |
|---|---|---|
| CAS or CEA | CAS:the patient who accepted carotid angioplasty due to catotid artery stenosis CEA:the patient who accepted carotid endarterectomy due to catotid artery stenosis Receives: Procedure: Carotid endarterectomy; Procedure: carotid angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
Measured: 30 days
The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
Measured: beyond 30 days to 12 months
Secondary outcomes (8)
Success rate of any procedure (CAS or CEA)
Success rate of any procedure (CAS or CEA)
Measured: 1 days
postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
Measured: 7 days
To observe the rate of restenosis during follow-up.
To observe the rate of restenosis during follow-up.
Measured: 12 months
Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
Measured: 12 months
Changes of the patients with mRS NIHSS Barthel Index score
Changes of the patients with mRS NIHSS Barthel Index score
Measured: 12 months
Postoperative patients with drug use
Postoperative patients with drug use
Measured: 12 months
Patient survival after 12 months
Patient survival after 12 months
Measured: 12 months
Patients hospitalized cost
Patients hospitalized cost
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Ling, MD, Principal investigator, Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994187
- Sponsor's protocol ID
- XW125-S004
- Acronym
- RECAS
- Status last verified
- Sep 2013
- First submitted
- 25 Sep 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang B, Ma Y, Wang T, Chen Y, Wang Y, Zhao Z, Chen D, Wang J, Xu X, Luo T, Hua Y, Ling F, Qureshi AI, Hong B, Jiao L; RECAS Trial Investigators. Carotid Endarterectomy and Stenting in a Chinese Population: Safety Outcome of the Revascularization of Extracranial Carotid Artery Stenosis Trial. Transl Stroke Res. 2021 Apr;12(2):239-247. doi: 10.1007/s12975-020-00835-8. Epub 2020 Jul 19.
PubMed 32686047
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Clinic Registration Study of Carotid Stenosis Revascularization
- ClinicalTrials.gov ID
- NCT01994187
- Acronym / sponsor ID
- RECAS / XW125-S004
- Conditions
- Carotid Stenosis, Surgery, Stroke
- Keywords
- Carotid stenosis, Angioplasty, Carotid endarterectomy, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 25 Nov 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.
Investigate the current situation of carotid stenosis therapy in China. Establish the data bank of carotid stenosis revascularization (CAS and CEA) in China ,in order to get best quality control of the therapy, as well as confirm the standard treatment for carotid stenosis.
Understand situation about the adverse events occurs after the revascularization (CAS and CEA), evaluate the health economics .
Detailed description
The carotid stenosis was one of the higher risk of the ischemia stroke in China.In the mean time ,more and more people accept revascularization because of carotid stenosis.NASCAT indicated that CEA is the "golden standard" of the therapy of the carotid stenosis.But in china , case the opposite,only little patient receive CEA,on the other hand , most patients received angioplasty.
Expected no less than 2100 cases within 2 years for the whole study. We choose 39 hospitals whose experienced in CAS or/and CEA spread all over the country as multiple centers for this clinic registration study. All cases inclusion must be continuously registration.
The subject choice:All registered patients must be signed informed consent to register for non intrusive research this study ,the researchers during the study period should be continuous registration in patients undergoing surgical treatment of carotid stenosis, to ensure that the selected participants reflect the target patient population.
Medical Center choice: This research for the study of the registration, therefore, when the choice, all the medical center will be based on market research data.
Primary endpoint or the main aim of this registration study is to observe the following details:
- The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
- The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
Secondary endpoint or the other aims of this registration study:
- Success rate of any procedure (CAS or CEA).
- postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
- To observe the rate of restenosis during follow-up.
- Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
- Changes of the patients with mRS NIHSS Barthel Index score.
- Postoperative patients with drug use.
- Patient survival after 12 months.
- Patients hospitalized cost during follow-up.
This study does not need to be random. The study is expected to begin in July 2013 in the first, participants in the group stage for two years, to the end of June 2015 into the group of patients after surgery, follow-up of at least 12 months after the last case the participants into groups and followed up for 12 months, is expected to be completed in June 2015.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAS or CEA | – | Procedure: Carotid endarterectomy, Procedure: carotid angioplastyCAS:the patient who accepted carotid angioplasty due to catotid artery stenosis CEA:the patient who accepted carotid endarterectomy due to catotid artery stenosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- one group:1050 cases of endarterectomy; the other group:1050 cases of carotid artery stent; totally:2100 cases of ravascularization for carotid stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid endarterectomyAlso: conventional carotid endarterectomy, Eversion carotid endarterectomy | Procedure or surgery | CAS or CEA |
| carotid angioplastyAlso: carotid angioplasty with stent | Procedure or surgery | CAS or CEA |
Primary outcome
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
Time frame: 30 days
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
Time frame: beyond 30 days to 12 months
The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
8 secondary outcomes
Success rate of any procedure (CAS or CEA)
Time frame: 1 days
postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
Time frame: 7 days
To observe the rate of restenosis during follow-up.
Time frame: 12 months
Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
Time frame: 12 months
Changes of the patients with mRS NIHSS Barthel Index score
Time frame: 12 months
Postoperative patients with drug use
Time frame: 12 months
Patient survival after 12 months
Time frame: 12 months
Patients hospitalized cost
Time frame: 5-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 32686047Yang B, Ma Y, Wang T, Chen Y, Wang Y, Zhao Z, Chen D, Wang J, Xu X, Luo T, Hua Y, Ling F, Qureshi AI, Hong B, Jiao L; RECAS Trial Investigators. Carotid Endarterectomy and Stenting in a Chinese Population: Safety Outcome of the Revascularization of Extracranial Carotid Artery Stenosis Trial. Transl Stroke Res. 2021 Apr;12(2):239-247. doi: 10.1007/s12975-020-00835-8. Epub 2020 Jul 19.
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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.
Feng Ling, MD principal investigator
Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
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 Stenosis and Surgery, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 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 China. 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?
Contact Liqun Jiao, MD (86-1083198899 ext. 8836, jiaoliqun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure. (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994187, which also lists 1 linked publication.
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 Nov 2013.