To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
Unnamed facility
Hirosaki, Aomori, Japan
Unnamed facility
Chikushino-shi, Fukuoka, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Nishinomiya, Hyōgo, Japan
Success Rate of Embolization in the Target Vessel
Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and \<80% disappearance; (4) mild embolization, \<50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.
Time frame: Day 1 (embolization) up to Day 30 after treatment
Success Rate for Operability of Embolization
Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.
Time frame: Day 1 (embolization) up to Day 30 after treatment
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Unnamed facility
Kanazawa, Ishikawa-ken, Japan
Unnamed facility
Kagoshima, Kagoshima-ken, Japan
Unnamed facility
Tsu, Mie-ken, Japan
Unnamed facility
Okayama, Okayama-ken, Japan
Unnamed facility
Chuo-ku, Tokyo, Japan
Unnamed facility
Minato-ku, Tokyo, Japan