Clinical trial NCT01994187: Revascularization of Extracranial Carotid Artery Stenosis
Official title: the Clinic Registration Study of Carotid Stenosis Revascularization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Stenosis
Surgery
Stroke
Keywords: Carotid stenosis
Angioplasty
Carotid endarterectomy
Stroke
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 2100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
timeFrame: 30 days
measure: The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
timeFrame: beyond 30 days to 12 months
Secondary outcomes:
measure: Success rate of any procedure (CAS or CEA)
timeFrame: 1 days
measure: postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
timeFrame: 7 days
measure: To observe the rate of restenosis during follow-up.
timeFrame: 12 months
measure: Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
timeFrame: 12 months
measure: Changes of the patients with mRS NIHSS Barthel Index score
timeFrame: 12 months
measure: Postoperative patients with drug use
timeFrame: 12 months
measure: Patient survival after 12 months
timeFrame: 12 months
measure: Patients hospitalized cost
timeFrame: 5-7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of neurosurgery, Xuanwu hospital
Study officials:
affiliation: Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
name: Feng Ling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.