A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation

Phase 3

Completed

• Conditions: Hypervascular Tumor and Arteriovenous Malformation
• Interventions: Device: E7040

• Registration Number: NCT01677624
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-03
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Results First Submitted: 2015-12-11
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Results First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E7040	E7040	-

Primary Outcome Measures

Name	Time	Method
Success Rate of Embolization in the Target Vessel	Day 1 (embolization) up to Day 30 after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Success Rate for Operability of Embolization	Day 1 (embolization) up to Day 30 after treatment	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.