Skip to content

Revascularization of Extracranial Carotid Artery Stenosis

the Clinic Registration Study of Carotid Stenosis Revascularization

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01994187
Acronym
RECAS
Enrollment
2100
Registered
2013-11-25
Start date
2013-07-31
Completion date
2015-06-30
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis, Stroke, Surgery

Keywords

Carotid stenosis, Angioplasty, Carotid endarterectomy, Stroke

Brief 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. 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: 1. The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure. 2. 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: 1. Success rate of any procedure (CAS or CEA). 2. postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events. 3. To observe the rate of restenosis during follow-up. 4. Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up. 5. Changes of the patients with mRS NIHSS Barthel Index score. 6. Postoperative patients with drug use. 7. Patient survival after 12 months. 8. 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.

Interventions

PROCEDURECarotid endarterectomy
PROCEDUREcarotid angioplasty

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.30 daysThe 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.beyond 30 days to 12 monthsThe participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.

Secondary

MeasureTime frameDescription
To observe the rate of restenosis during follow-up.12 monthsTo observe the rate of restenosis during follow-up.
Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.12 monthsStroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
Changes of the patients with mRS NIHSS Barthel Index score12 monthsChanges of the patients with mRS NIHSS Barthel Index score
Success rate of any procedure (CAS or CEA)1 daysSuccess rate of any procedure (CAS or CEA)
Patient survival after 12 months12 monthsPatient survival after 12 months
Patients hospitalized cost5-7 daysPatients hospitalized cost
Postoperative patients with drug use12 monthsPostoperative patients with drug use
postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.7 dayspostoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.

Countries

China

Contacts

Primary ContactLiqun Jiao, MD
jiaoliqun@gmail.com86-1083198899
Backup ContactYanfei Chen, MD
chenyanflying@126.com86-1083198899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026