Skip to content

Study on the efficacy and safety of stenting combined with Urinary Kallidinogenase in patients with vascular stenosis of the internal carotid artery system

Study on the efficacy and safety of stenting combined with Urinary Kallidinogenase in patients with vascular stenosis of the internal carotid artery system

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053351
Enrollment
Unknown
Registered
2021-11-19
Start date
2021-11-16
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Vascular stenosis of the internal carotid artery system

Interventions

Experimental group:Basic treatment + intravenous Urinary Kallidinogenase 0.15PNA/d
Control group:Basic treatment

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Symptomatic patients, who have had nondisabling ischemic stroke or TIA within 6 months, and ipsilateral internal carotid artery diameter stenosis of more than 50% by noninvasive imaging or angiography; asymptomatic patients, by Non-invasive imaging or angiography found that the diameter of the ipsilateral internal carotid artery was narrowed by more than 70%; 2. Enrollment aged 18 to 80 years; 3. The consciousness is clear, and can cooperate with it to complete the evaluation of cognitive function; 4. Tolerable to surgery; 5. Before the start of the trial, the patients and their legal representatives voluntarily signed an informed consent form approved by the ethics committee.

Exclusion criteria

Exclusion criteria: 1. Severe neurological disorder has caused severe disability; 2. Those who have experienced massive cerebral infarction in the acute phase of cerebral hemorrhage and other hemorrhagic diseases or within 4 weeks; 3. Severe disturbance of consciousness: GCS score <= 8; 4. Those who have used ACEI drugs before administration of uracrine for injection and have not exceeded 5 half-lives (according to the specific drug instructions) and need to receive ACEI drugs during this study; 5. Severe heart, liver, kidney dysfunction, coagulation dysfunction or those who cannot tolerate surgery; 6. Diagnosed or suffered from any malignancy (except basal cell carcinoma) within 5 years prior to the start of the study; 7. Patients who are pregnant, breastfeeding or have the possibility of pregnancy and those who plan to become pregnant; 8. Those who are allergic to or intolerable to uricrine for injection in the past.

Design outcomes

Primary

MeasureTime frame
cerebral autoregulation;cerebral blood perfusion;

Secondary

MeasureTime frame
neurological function deficits assessment;cognitive function assessment;inflammatory factors;

Countries

China

Contacts

Public ContactFan Yuhua

The First Affiliated Hospital of Sun Yat-Sen University

2397894478@qq.com+86 13600086863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026