NCT01994187

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 25, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

September 25, 2013

Last Update Submit

November 20, 2013

Conditions

Carotid StenosisSurgeryStroke

Keywords

Carotid stenosisAngioplastyCarotid endarterectomyStroke

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    beyond 30 days to 12 months

Secondary Outcomes (8)

  • Success rate of any procedure (CAS or CEA)

    1 days

  • postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.

    7 days

  • To observe the rate of restenosis during follow-up.

    12 months

  • Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.

    12 months

  • Changes of the patients with mRS NIHSS Barthel Index score

    12 months

  • +3 more secondary outcomes

Study Arms (1)

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

Procedure: Carotid endarterectomyProcedure: carotid angioplasty

Interventions

Carotid endarterectomyPROCEDURE
Also known as: conventional carotid endarterectomy, Eversion carotid endarterectomy
CAS or CEA
carotid angioplastyPROCEDURE
Also known as: carotid angioplasty with stent
CAS or CEA

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurosurgery, Xuanwu hospital

Beijing, 100053, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32686047DERIVED

MeSH Terms

Conditions

Carotid StenosisStroke

Interventions

Endarterectomy, CarotidStents

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProstheses and ImplantsEquipment and Supplies

Study Officials

  • Feng Ling, MD

    Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqun Jiao, MD

CONTACT

86-1083198899jiaoliqun@gmail.com

Yanfei Chen, MD

CONTACT

86-1083198899chenyanflying@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2013

First Posted

November 25, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 25, 2013

Record last verified: 2013-09

Locations

CN(1)