Revascularization of Extracranial Carotid Artery Stenosis

Stroke Clinical Trial

— RECAS  

Official title:

the Clinic Registration Study of Carotid Stenosis Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01994187
• Other study ID #: XW125-S004
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2013
• Last updated: November 20, 2013
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2013
• Source: Xuanwu Hospital, Beijing
• Contact: Liqun Jiao, MD
• Phone: 86-1083198899
• Email: jiaoliqun[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical 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.

Understand situation about the adverse events occurs after the revascularization (CAS and CEA), evaluate the health economics .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic
• Stroke
• Surgery

Intervention

Procedure:
• Carotid endarterectomy

• carotid angioplasty

Locations

Country	Name	City	State
China	Department of neurosurgery, Xuanwu hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Success rate of any procedure (CAS or CEA)	Success rate of any procedure (CAS or CEA)	1 days	Yes
Secondary	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.	7 days	Yes
Secondary	To observe the rate of restenosis during follow-up.	To observe the rate of restenosis during follow-up.	12 months	Yes
Secondary	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.	12 months	Yes
Secondary	Changes of the patients with mRS NIHSS Barthel Index score	Changes of the patients with mRS NIHSS Barthel Index score	12 months	Yes
Secondary	Postoperative patients with drug use	Postoperative patients with drug use	12 months	Yes
Secondary	Patient survival after 12 months	Patient survival after 12 months	12 months	Yes
Secondary	Patients hospitalized cost	Patients hospitalized cost	5-7 days	Yes