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Trial record 6 of 113 for:    Recruiting, Not yet recruiting, Available Studies | Common carotid artery

Carotid Artery Stenting Without Protection

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ClinicalTrials.gov Identifier: NCT02781181
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Acibadem University

Brief Summary:

A recent randomized Carotid artery stenting (CAS) trial in which carotid protection device (CPD)s were used to demonstrate equivalence with carotid endarterectomy (CEA) by achieving noninferiority regarding periprocedural risk. However, the clinical efficacy and safety of CPDs are still a matter of controversy. It has been argued that the limited reduction provided by CPDs may be due to the devices themselves. Probably, they serve as sources for emboli during the procedure or removal technique. In general, 30- day adverse outcome for CAS with the use of CPDs seems not to be different from the outcome without CPDs.

Thus, the main goal in this study is to test the hypothesis that CAS without CPD usage is as safe as in those patients who undergo CAS with CPD neuroprotection.


Condition or disease Intervention/treatment Phase
Carotid Arteries Device: CAS with CPD Other: CAS without CPD Not Applicable

Detailed Description:
The Carotid Artery Stenting without Embolic Protection (CASWEP) trial is designed in a prospective, randomized, multi-center fashion to determine if CAS without CPD is feasible and safe in patients with symptomatic or asymptomatic severe carotid stenosis. After the exclusion criteria were applied 200 patients were divided as 100 patients in the CAS with CPD arm and 100 patients in the CAS without CPD arm. The study population includes patients with severe carotid artery stenosis referred to the to the 4 study center hospitals.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carotid Artery Stenting Without Embolic Protection: A Randomized Multicenter Trial (the CASWEP Trial)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
CAS with CPD
CAS performed under neuroprotection
Device: CAS with CPD
using a neuroprotection device

Active Comparator: CAS without CPD
CAS without neuroprotection
Other: CAS without CPD
No Neuroprotection




Primary Outcome Measures :
  1. The number of patients experiencing death, stroke, transient ischemic attack (TİA), or Myocardial infarction at 1 month follow up [ Time Frame: 1 month ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic patients with ≥ 50% ipsilateral carotid stenosis by angiography, ≥70% by duplex ultrasound, or ≥70% by Computerized tomography (CT) angiography or Magnetic Resonance (MR) angiography if the stenosis on ultrasonography was 50% to 69%.
  • Asymptomatic patients with ≥60% stenosis by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if the stenosis on ultrasonography was 50% to 69%.

Exclusion Criteria:

  • Previous stroke within 1 month before CAS
  • Total occlusion,
  • Visible thrombus at the lesion site
  • Bleeding diathesis
  • Cerebral vascular malformation,
  • Degenerative cerebral diseases
  • Cerebral tumors
  • Illness impeding informed consent
  • Life expectancy<2 years
  • Previous CEA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781181


Contacts
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Contact: Sevket Gorgulu, MD 05052379068 sevket5@yahoo.com

Locations
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Turkey
Adapazari Education and Research Hospital Recruiting
Adapazari, Turkey
Contact: ERSAN TATLI, MD       <ersantatli@yahoo.com>,   
Adiyaman University Not yet recruiting
Adiyaman, Turkey
Contact: Musa Çakıcı, MD         
Acibadem University Recruiting
İstanbul, Turkey
Contact: Sevket Gorgulu, MD       sevket5@yahoo.com   
Principal Investigator: Sevket Gorgulu, MD         
Koşuyolu Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: SELÇUK PALA, MD         
Marmara University Not yet recruiting
Istanbul, Turkey
Contact: KÜRŞAT TİGEN, MD         
Mehmet Akif Ersoy Education and Training Hospital Recruiting
Istanbul, Turkey
Contact: AYDIN YILDIRIM, MD       <aydinyildirim1@hotmail.com>,   
Principal Investigator: Aydın Yıldırım, MD         
Sponsors and Collaborators
Acibadem University
Investigators
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Study Director: SEVKET GORGULU, MD Acibadem University

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Responsible Party: Acibadem University
ClinicalTrials.gov Identifier: NCT02781181     History of Changes
Other Study ID Numbers: AcibademU
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Acibadem University:
Stenting
Protection device
EPD usage