Revascularization of Extracranial Carotid Artery Stenosis (RECAS)

November 20, 2013 updated by: Xuanwu Hospital, Beijing

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Department of Neurosurgery, Xuanwu hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 endarterectomy
Other Names:
  • conventional carotid endarterectomy
  • Eversion carotid endarterectomy
Procedure: carotid angioplasty
Other Names:
  • carotid angioplasty with stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
beyond 30 days to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of any procedure (CAS or CEA)
Time Frame: 1 days
Success rate of any procedure (CAS or CEA)
1 days
postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
Time Frame: 7 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.
Time Frame: 12 months
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.
Time Frame: 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
Time Frame: 12 months
Changes of the patients with mRS NIHSS Barthel Index score
12 months
Postoperative patients with drug use
Time Frame: 12 months
Postoperative patients with drug use
12 months
Patient survival after 12 months
Time Frame: 12 months
Patient survival after 12 months
12 months
Patients hospitalized cost
Time Frame: 5-7 days
Patients hospitalized cost
5-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Feng Ling, MD, Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XW125-S004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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