WithdrawnNo phase
Distal Versus Proximal Protection on Cerebral Microembolization During High-risk Carotid Artery Stenting
Key facts
- Who runs it
- Xuanwu Hospital, Beijing
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 1 May 2021
- Ended
- 1 Feb 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- proximal embolism protection device
- distal embolism protection device
- Record updated
- 12 October 2022
- Why it stopped
- device unavailable
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Male and female patients 40 years of age and older
- Asymptomatic patients with internal carotid artery stenosis≥70% on angiography
- Symptomatic patients with internal carotid artery stenosis≥50% on angiography
- High-intensity Signal in the relevant plaques on the TOF-MRA
- Anatomic characteristics of the lesions that made it possible to use either type of embolism protective device (proximal or distal)
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Medical Ethics Committee, Institutional Review Board, or Human Research Ethics Committee
Who cannot take part
- Chronic or paroxysmal atrial fibrillation treated with oral anticoagulation
- Extensive ipsilateral or disabling stroke(mRS≥2)
- Ischemic ipsilateral stroke in 15 days, with significant new ischemic lesions on the DWI image
- Acute coronary syndrome in the 30-day period before the procedure
- Patient has a history of bleeding diathesis within 1 month or coagulopathy or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
- Intolerance or allergic reaction to a study medication without a suitable management alternative
- Ipsilateral intracranial artery stenosis which needs to be treated at the same time
- Extremely calcified aortic arc that compromised the origin of the common carotid artery or the brachiocephalic trunk
- Pregnant or lactating female patient
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
A multicenter, prospective, outcome-assessor-blinded, randomized controlled trial study (MOSCASH) is designed to compare the efficiency of distal and proximal embolism protection devices during carotid angioplasty and stenting (CAS) procedure of patients with high-intensity signal in the plaque on the time-of-flight magnetic resonance angiography(TOF-MRA) .
The 2 groups in the trial
- CAS with proximal protectionTreatment being tested
using proximal embolism protection device during CAS
Treatment: proximal embolism protection device
- CAS with distal protectionExisting treatment, for comparison
using distal protection device during CAS
Treatment: distal embolism protection device
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 October 2022