Trial record 3 of 52 for:    Open Studies | "Carotid Stenosis"

Revascularization of Extracranial Carotid Artery Stenosis (RECAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Xuanwu Hospital, Beijing
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT01994187
First received: September 25, 2013
Last updated: November 20, 2013
Last verified: September 2013
  Purpose

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 .


Condition Intervention
Carotid Stenosis
Surgery
Stroke
Procedure: Carotid endarterectomy
Procedure: carotid angioplasty

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: the Clinic Registration Study of Carotid Stenosis Revascularization

Resource links provided by NLM:


Further study details as provided by Xuanwu Hospital, Beijing:

Primary Outcome Measures:
  • The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 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 ] [ Designated as safety issue: Yes ]
    The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.


Secondary Outcome Measures:
  • Success rate of any procedure (CAS or CEA) [ Time Frame: 1 days ] [ Designated as safety issue: Yes ]
    Success rate of any procedure (CAS or CEA)

  • postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.

  • To observe the rate of restenosis during follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To observe the rate of restenosis during follow-up.

  • Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.

  • Changes of the patients with mRS NIHSS Barthel Index score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Changes of the patients with mRS NIHSS Barthel Index score

  • Postoperative patients with drug use [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Postoperative patients with drug use

  • Patient survival after 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patient survival after 12 months

  • Patients hospitalized cost [ Time Frame: 5-7 days ] [ Designated as safety issue: Yes ]
    Patients hospitalized cost


Estimated Enrollment: 2100
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: carotid angioplasty with stent

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994187

Contacts
Contact: Liqun Jiao, MD 86-1083198899 ext 8836 jiaoliqun@gmail.com
Contact: Yanfei Chen, MD 86-1083198899 ext 8836 chenyanflying@126.com

Locations
China
Department of neurosurgery, Xuanwu hospital Recruiting
Beijing, China, 100053
Contact: Jiao Li qun, MD    86-10-83198899 ext 8836    jiaoliqun@gmail.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Principal Investigator: Feng Ling, MD Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
  More Information

No publications provided

Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT01994187     History of Changes
Other Study ID Numbers: XW125-S004
Study First Received: September 25, 2013
Last Updated: November 20, 2013
Health Authority: China: Ministry of Health

Keywords provided by Xuanwu Hospital, Beijing:
Carotid stenosis
Angioplasty
Carotid endarterectomy
Stroke

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014