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Carotid Artery Stenting Without Protection

A

Acibadem University

Status

Completed

Conditions

Carotid Arteries

Treatments

Device: CAS with CPD
Other: CAS without CPD

Study type

Interventional

Funder types

Other

Identifiers

NCT02781181
AcibademU

Details and patient eligibility

About

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.

Full 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.

Study participants After the exclusion criterias were applied 279 patients were divided as 139 patients in the CAS with CPD arm and 140 patients in the CAS without CPD arm. Our study population includes patients with severe carotid artery stenosis referred to the 3 study center hospitals.

Enrollment

279 patients

Sex

All

Volunteers

No Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

279 participants in 2 patient groups

CAS with CPD
Other group
Description:
CAS performed under neuroprotection
Treatment:
Device: CAS with CPD
CAS without CPD
Active Comparator group
Description:
CAS without neuroprotection
Treatment:
Other: CAS without CPD

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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