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Intravenous Cerebral Angiography in Balloon Test Occlusion

Exploratory Study on the Utility of Intravenous Cerebral Angiography in Balloon Test Occlusion - IV-BTO study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032240337
Enrollment
20
Registered
2024-09-17
Start date
2024-10-21
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

Patients scheduled for carotid artery occlusion testing

Interventions

Balloon test occlusion by cerebral angiography using intravenous injection

Sponsors

Matsumaru Yuji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years old or older 2. Patients scheduled for carotid artery occlusion testing 3. Patients who have received sufficient explanation of the trial and have provided written consent based on their full understanding and free will

Exclusion criteria

Exclusion criteria: 1. Patients who cannot use heparin 2. Patients with renal dysfunction (eGFR < 60) 3. Patients with reduced left ventricular ejection fraction (< 40%) 4. Patients with symptomatic heart failure requiring hospitalization and treatment 5. Pregnant women or women who may be pregnant 6. Breastfeeding women 7. Patients with a history of iodine allergy 8. Other patients deemed inappropriate by the principal investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
To evaluate the delay (in seconds) of cortical vein visualization during cerebral angiography using intraarterial and venous injection and assess its correlation coefficient Two contrast-enhanced images obtained from the same subject will be individually evaluated by three specialists: two neurologists or neurosurgeons from the institution where the imaging was conducted and one neurologist or neurosurgeon from another facility. They will each assess the images and determine the delay in seconds.

Secondary

MeasureTime frame
A. To score the quality of images between intraarterial and intravenous injections. Select one of the four categories for the ability to detect cerebral cortical veins: 1. There is no difference in the quality of venous-phase images, and evaluation of cortical veins is possible. 2. The quality of venous-phase images differs, but this does not hinder the evaluation of cortical veins. 3. The quality of venous-phase images differs, hindering the evaluation of cortical veins, but evaluation is still possible. 4. There is a difference in the quality of venous-phase images, and evaluating cortical veins is impossible. B. Consider factors influencing the correlation coefficient of the primary outcome. C. Comparison of fluoroscopy time (seconds), radiation exposure (mGy), and contrast agent volume (cc) during the test. D. To score the sensation of heat or discomfort felt during the transarterial and transvenous injection. Score from 1 to 10, where 1 is the weakest and ten is the strongest. E. Presence of complications at the puncture site. F. Presence of brain infarction in cases where the internal carotid artery on the trial side was occluded, NIHSS and mRS three months after occlusion

Contacts

Public ContactKoji Hirata

University of Tsukuba Hospital

hirata.koji.fp@ms.hosp.tsukuba.ac.jp+81-29-853-3119

Outcome results

None listed

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