Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization

NCT ID: NCT04497181

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

"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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"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 team leader is Shanghai Changhai Hospital and the Second Affiliated Hospital of Zhejiang University School of Medicine. 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. Sample: 228 cases. The subjects will be randomly assigned to the test group or the control group, with 114 cases in each group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Group Type EXPERIMENTAL

Coil embolization surgery

Intervention Type DEVICE

Embolization of aneurysms with various coils system

Control group

Group Type SHAM_COMPARATOR

Coil embolization surgery

Intervention Type DEVICE

Embolization of aneurysms with various coils system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coil embolization surgery

Embolization of aneurysms with various coils system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Other situations that the researcher judges are not suitable for inclusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

jianmin zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of neurosurgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jianmin Zhang

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

jianmin zhang, M.D.

Role: CONTACT

+86 0571 87784755

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jianmin Zhang, M.D., Ph.D.

Role: primary

+86 0571 87784755.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I2017001223

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.