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

"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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Coil embolization surgery

Detailed Description

"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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Jianmin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group	Device: Coil embolization surgery; Embolization of aneurysms with various coils system
SHAM_COMPARATOR: Control group	Device: Coil embolization surgery; Embolization of aneurysms with various coils system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embolization success rate	Embolization success rate at 6-month after surgery	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aneurysm recurrence rate	Aneurysm recurrence rate at 6-month after surgery	6 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2010
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): August 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: intracranial aneurysms embolization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: I2017001223

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No