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A pilot study on the safety and efficacy of an antithrombotic therapy during carotid artery stenting (CAS).

A pilot study on the safety and efficacy of an antithrombotic therapy during carotid artery stenting (CAS). - SAITAMA-CAS:A pilot study on the safety and efficacy of an anti-thrombotic treatment in accordance with a CAS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002674
Enrollment
50
Registered
2010-02-01
Start date
2010-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Those patients who have stenosis of more than 50% of the common carotid artery or internal carotid artery (diagnosed by ultrasonography or angiography), with neurological symptoms (transient cerebral ischemic stroke or cerebral stroke), or who have stenosis of more than 80% of the common carotid artery or internal carotid artery (diagnosed by ultrasonography or angiography) even if there are no neurological symptoms.

Interventions

Patients are to be administered concomitantly with aspirin 100 mg once a day and cilostazol 100 mg or 200 mg twice a day from at least 3 days before CAS. The combination therapy is to be continued fo

Sponsors

Saitama medical university international medical center Department of Endovascular Neurosurgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Those patients for whom surgical treatment (carotid endarterectomy [CEA]) is difficult, and whose target vessel diameter is between 5 to 9 mm, and who meet either of the following criteria: Having atheromatous stenosis of more than 50% of the common carotid artery or internal carotid artery that had been diagnosed by ultrasonography or angiography, with neurological symptoms (transient cerebral ischemic stroke or cerebral stroke). Having atheromatous stenosis of more than 80% of the common carotid artery or internal carotid artery that had been diagnosed by ultrasonography or angiography, even if there are no neurological symptoms. 2 Those patients who can be administered concomitantly with aspirin and cilostazol from at least 3 days before CAS.

Exclusion criteria

Exclusion criteria: 1Ischemic stroke within previous 48 hr 2Presence of intraluminal thrombus 3Total occlusion of target vessel 4Intracranial aneurysm > 9 mm in diameter 5Need for more than two stents 6History of bleeding disorder 7Percutaneous or surgical intervention planned within next 30 days 8Life expectancy < 1 year 9Ostial lesion of common carotid artery 10Ostial lesion of brachiocephalic artery 11Contraindication of Pletaal 12Contraindication of Aspirin

Design outcomes

Primary

MeasureTime frame
1Cumulative incidence of death, stroke, or myocardial infarction within 30 days after CAS. 2Cumulative incidence of death or ipsilateral stroke between 31 days and 1 year after CAS.

Secondary

MeasureTime frame
1Cumulative number of target-vessel revascularization at 1 year after CAS. 2Cumulative number of restenosis at 1 year after CAS. Restenosis is defined as 50% or more stenosis diagnosed by angiography when cerebral infarction is suspected.

Countries

Japan

Contacts

Public ContactFumitaka Yamane

Saitama medical university international medical center Department of Endovascular Neurosurgery

fyamane@saitama-med.ac.jp042-984-4531

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026