NCT04497181

Brief Summary

"Study on the effectiveness and safety of the coil system for the treatment of intracranial aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The trial design is: prospective, multi-center, randomized, open, parallel positive control, and non-inferiority test. Purpose: To compare the data obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms embolization.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
10.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

10.8 years

First QC Date

July 26, 2020

Last Update Submit

July 29, 2020

Conditions

Intracranial Aneurysm

Keywords

intracranial aneurysms embolization

Outcome Measures

Primary Outcomes (1)

  • Embolization success rate

    Embolization success rate at 6-month after surgery

    6 months

Secondary Outcomes (1)

  • Aneurysm recurrence rate

    6 months

Study Arms (2)

Experimental group

EXPERIMENTAL
Device: Coil embolization surgery

Control group

SHAM COMPARATOR
Device: Coil embolization surgery

Interventions

Coil embolization surgeryDEVICE

Embolization of aneurysms with various coils system

Control groupExperimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An intracranial aneurysm was diagnosed by DSA examination of whole cerebral blood vessels, and it is planned to use a coil for the embolization of the target aneurysm
  • The subject can understand the purpose of the research, show sufficient compliance with the research protocol, and sign an informed consent form

You may not qualify if:

  • Multiple aneurysms
  • Blood alveolar aneurysm, fusiform aneurysm, pseudoaneurysm, dissecting aneurysm, infectious aneurysm with arteriovenous malformation
  • mRS score ≥ 3
  • Hunt and Hess rating≥4
  • Emergency ruptured aneurysms who need stent
  • The target aneurysm has previously been treated with vascular embolization or surgery
  • Patients with severe stenosis of the tumor-bearing artery
  • PLT\<60\*10⁹ or INR\>1.5
  • Having vital organ failure or other serious diseases
  • Received major surgery within 30 days before enrollment, or planned to undergo surgery within 90 days after enrollment
  • History of allergy or contraindications to antiplatelet drugs, anticoagulant drugs, anesthetics, or contrast agents
  • Patiens with a history of allergies to platinum and tungsten metals
  • Life expectancy \<12 months
  • Pregnant or breastfeeding women
  • Participated in other drug or device clinical trials within 1 month before signing the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianmin Zhang

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • jianmin zhang, M.D.

    Department of neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jianmin zhang, M.D.

CONTACT

+86 0571 87784755zjm135@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2020

First Posted

August 4, 2020

Study Start

March 1, 2010

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 4, 2020

Record last verified: 2020-07

Locations

CN(1)