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NCT05416853: RACE-CAS
Radial Versus Femoral Access For Carotid Artery Stenting
NA trial testing Carotid Artery Stenting (CAS) in Ischemic Stroke in 3,000 participants. Participants enrolled and being followed up; not accepting new ones.
24 March 2025
Quick facts
| Lead sponsor | The First Affiliated Hospital of University of Science and Technology of China |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3,000 |
| Start date | 4 July 2022 |
| Primary completion | 24 March 2025 |
| Estimated completion | 20 March 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Carotid Artery Stenting (CAS)
Conditions studied
- Ischemic Stroke — all drugs for Ischemic Stroke →
- Carotid Stenosis — all drugs for Carotid Stenosis →
- Cerebral Revascularization — all drugs for Cerebral Revascularization →
- Carotid Artery Diseases — all drugs for Carotid Artery Diseases →
Sponsor
The First Affiliated Hospital of University of Science and Technology of China
Who can join
18 and older, any sex, with Ischemic Stroke or Carotid Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. The transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for CAS. The radial artery is an ideal puncture site for cerebrovascular intervention. Studies have shown that nerve intervention through radial artery approach can complete most cerebrovascular intervention procedures, including cerebral angiography, carotid artery stent implantation, vertebral artery stent implantation, intracranial artery stent implantation, mechanical thrombectomy, aspiration, intra-arterial thrombolysis and so on. However, the current studies are based on single center small sample studies, and there has been still a lack of large sample randomized controlled experiments to verify the safety and effectiveness of CAS in transradial artery (TRA) . Objective: To evaluate the efficacy and safety of CAS via TRA in patients with carotid artery stenosis through a multicenter, prospective and randomized study. Study design: This study is a randomized, open label, multicenter, parallel controlled trial. A non-inferiority test is performed to compare the primary end point between the experimental group and the control group. The experimental group will undergo carotid stent implantation via radial artery approach, while the control group will use femoral artery approach. Study population: Adult patients with symptomatic carotid-artery stenosis ≥50% or asymptomatic stenosis ≥70%. Study outcomes: Primary end points: The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure Secondary end points:1.The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 48 hours post-procedure. 2. The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure. 3. The incidence of death within 48 hours / 30 days post-procedure. 4. The incidence of new-onset stroke within 48 hours / 30 days post-procedure. 5. The incidence of myocardial infarction within 48 hours / 30 days post-procedure. 6. The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure. Other end points: 1. Successful rate of cerebral angiography. 2. Successful rate of CAS. 3. Degree of patient-reported comfort. 4. Operation time. 5. NIHSS score changes within 5-7 days post-procedure. 6. mRS score score within 30 days post-procedure. Safety outcomes: 1.Occurrence of all adverse events. 2. AEs related to operation and device. 3. Incidence of adverse event of special interest.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
- PubMed search for NCT05416853
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Carotid Artery Stenting (CAS)
Trials testing the same drug.
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Other recruiting trials for Ischemic Stroke
Currently open trials in the same condition.
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Other The First Affiliated Hospital of University of Science and Technology of China trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05416853 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of University of Science and Technology of China
- Last refreshed: 5 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05416853.
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