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CATCH [Short Name for: Coil Application Trial in China] (CATCH)

Primary Purpose

Intracranial Aneurysm

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Coil Embolization System

Cotrol device from Medronic

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Coils

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;
Intracranial ruptured or unruptured, single, previously untreated, saccular aneurysm diagnosed by CTA, MRA, DSA or other similar neuroimaging examination;
The maximum diameter of target aneurysm ≤24mm;
Baseline modified Rankin score (mRS) ≤2 points;
Baseline Hunt - Hess scores of patients with ruptured aneurysm ≤ Ⅲ;
The target aneurysm can be embolized in one operation;
The patient or the patient's guardian signs the informed consent voluntarily and is willing to accept follow-up.

Exclusion Criteria:

Clear allergy, resistance or contraindication to antiplatelet drugs, anticoagulants, contrast agents and/or anesthetics.
Definite allergy to platinum, tungsten and/or any substances of coils.
Subjects who are not suitable for anesthesia or endovascular treatment, such as those suffering from severe respiratory system, liver and kidney diseases or coagulation disorders (such as hemophilia).
Target aneurysm parent vessel stenosis ≥70%.
Anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
The target aneurysm has previously received surgery or other endovascular treatment.
Ruptured aneurysm requiring stent-assisted embolization.
The target aneurysm is hemangioid aneurysm, dissected aneurysm, fusiform aneurysm, infectious aneurysm, pseudoaneurysm, or arteriovenous malformation, or aneurysm associated with Moyamoya disease.
Major surgery was performed within 30 days before enrollment, or surgery was planned within 90 days after enrollment.
Patients with active infection at puncture point or other serious infection are not suitable for endovascular treatment.
Illness with a potential risk of sudden death.
Subjects with intracranial space-occupying lesions (e.g., intracranial tumor, abscess, etc.) or who are receiving radiotherapy for their head and neck.
Long-term treatment with anticoagulant drugs (such as warfarin) is required.
Having cognitive impairment, psychiatric disorder or other medical condition that may affect the data evaluation or trial results.
Unable to understand the trial or has a record of noncompliance with medical advice.
Taking banned medicine.
Life expectancy less than 1 year, may not complete follow-up.
Women in pregnancy or lactation, or women with positive pregnancy test.
Subjects who are participating in clinical trials of other drugs or devices and have not reached the end point of the trial, or are expected to participate in clinical trials of other drugs or devices.
Investigators do not consider it appropriate to participate in this study.

Sites / Locations

MicroportNT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coil Embolization System

Control device from Medronic

Arm Description

Coil Embolization System,or deposits coils in the aneurysm sac by electrolytical detachment; coil types include Complex Finish, Complex Frame,and Helical. The coils are made of a platinum - tungsten alloy, have a minimum diameter of 2 mm and a maximum diameter of 24mm.

Control device from Medronic,include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils, which are manufactured by ev3 (Medtronic, Irvine, California, USA);

Outcomes

Primary Outcome Measures

Raymond Scale

For the MicroPort NeuroTech Coil Embolization System, this endpoint will be based upon the 6-month Core Lab identification of patients with "Successful occlusion" rate: % of subjects who at 6 months' post coiling, reported as a combination of Raymond 1 and Raymond 2 outcomes (95%-100%). The endpoint will be expressed as a percentage of all evaluable subjects with complete and nearly complete (95%-100%) occlusion in the context of the whole population of evaluable subjects (n/N).

Secondary Outcome Measures

Modified Rankin Scale

6-months post-treatment "Clinical Worsening", "Clinical Worsening" will be calculated as the percentage of subjects who meet the following condition: Final mRS score is more than 2 and is at least 1 point higher than the pre study measurement. For most subjects, this will be determined at the 6-months follow up visit. However, for those subjects whose trial participation is prematurely shortened, as a result of death (mRS will count as 6) or very serious device or procedure related debilitating injury, their final mRS determination will be counted, as the most recent score at the time of leaving the study.

Full Information

NCT ID

NCT02990156

First Posted

December 1, 2016

Last Updated

April 7, 2022

Sponsor

MicroPort NeuroTech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02990156

Brief Title

CATCH [Short Name for: Coil Application Trial in China]

Acronym

CATCH

Official Title

Prospective, Randomized, Controlled, Open Label, All China, Multi-Center, Registration Trial of the MICROPORT NEUROTECH Coil Embolization System for the Traetment of Intracranial Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 8, 2017 (Actual)

Primary Completion Date

March 25, 2019 (Actual)

Study Completion Date

November 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MicroPort NeuroTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the MicroPort NeuroTech Coil Embolization System in the treatment of intracranial aneurysms.

Detailed Description

A cerebral aneurysm (also known as an intracranial or intracerebral aneurysm) is a weak or thin spot on a blood vessel in the brain that balloons out and fills and intermixes with parent artery blood. Aneurysms can occur at any age. Global incidence varies by country, with reports of prevalence ranging from 5.1 to 19.6 cases per 100,000 persons. With the development of imaging technology and the greater attention paid by people to their overall health,there will be more aneurysms be detected. The combination of sophisticated imaging equipment, more frequent use of imaging in patients, and the aforementioned emphasis on optimum health, has led to a greater proportion of asymptomatic aneurysms being discovered. The most common type of aneurysms are saccular; and, aneurysms are more likely to occur in women. The most devastating presentation of an intracranial aneurysm is subarachnoid hemorrhage (SAH). It is estimated that, on average, five percent of the population is afflicted and the incidence of aneurysm rupture (SAH) is between 6 and 9 per 1000 000 individuals . Mortality can approach 50%, with fewer than 60% of survivors returning to independent living. Invasive treatment of aneurysms began with an open surgical procedure referred to as 'surgical clipping'. This treatment was once considered the gold standard treatment for aneurysms. The first neurovascular interventional medical device was the Guglielmi Detachable Coil (GDC), which was developed and tested in the mid-1990s and was introduced by Dr. Guido Guglielmi and Target Therapeutics, Fremont, California. These bare platinum coils were electrolytically detached for placement in the aneurysm sac. It took approximately one decade to prove coiling superiority over surgical clipping, after publication of the results of the ISAT Study. Since that time, coils have become more sophisticated in makeup and conformation. Coil use is also a mainstay for neurovascular procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysm

Keywords

Coils

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

334 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Coil Embolization System

Arm Type

Experimental

Arm Description

Arm Title

Control device from Medronic

Arm Type

Active Comparator

Arm Description

Control device from Medronic,include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils, which are manufactured by ev3 (Medtronic, Irvine, California, USA);

Intervention Type

Device

Intervention Name(s)

Coil Embolization System

Intervention Description

deposits coils in the aneurysm sac by electrolytical detachment; coil types include Complex Finish, Complex Frame, and Helical. The coils are made of a platinum - tungsten alloy, have a minimum diameter of 2 mm and a maximum diameter of 24mm. The intended use of the Microport NeuroTech Coil Embolization System is for the endovascular embolization of intracranial aneurysms.

Intervention Type

Device

Intervention Name(s)

Cotrol device from Medronic

Intervention Description

Control device from Medronic (include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils) are manufactured by ev3 (Medtronic, Irvine, California, USA);

Primary Outcome Measure Information:

Title

Raymond Scale

Description

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Modified Rankin Scale

Description

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent; Intracranial ruptured or unruptured, single, previously untreated, saccular aneurysm diagnosed by CTA, MRA, DSA or other similar neuroimaging examination; The maximum diameter of target aneurysm ≤24mm; Baseline modified Rankin score (mRS) ≤2 points; Baseline Hunt - Hess scores of patients with ruptured aneurysm ≤ Ⅲ; The target aneurysm can be embolized in one operation; The patient or the patient's guardian signs the informed consent voluntarily and is willing to accept follow-up. Exclusion Criteria: Clear allergy, resistance or contraindication to antiplatelet drugs, anticoagulants, contrast agents and/or anesthetics. Definite allergy to platinum, tungsten and/or any substances of coils. Subjects who are not suitable for anesthesia or endovascular treatment, such as those suffering from severe respiratory system, liver and kidney diseases or coagulation disorders (such as hemophilia). Target aneurysm parent vessel stenosis ≥70%. Anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy. The target aneurysm has previously received surgery or other endovascular treatment. Ruptured aneurysm requiring stent-assisted embolization. The target aneurysm is hemangioid aneurysm, dissected aneurysm, fusiform aneurysm, infectious aneurysm, pseudoaneurysm, or arteriovenous malformation, or aneurysm associated with Moyamoya disease. Major surgery was performed within 30 days before enrollment, or surgery was planned within 90 days after enrollment. Patients with active infection at puncture point or other serious infection are not suitable for endovascular treatment. Illness with a potential risk of sudden death. Subjects with intracranial space-occupying lesions (e.g., intracranial tumor, abscess, etc.) or who are receiving radiotherapy for their head and neck. Long-term treatment with anticoagulant drugs (such as warfarin) is required. Having cognitive impairment, psychiatric disorder or other medical condition that may affect the data evaluation or trial results. Unable to understand the trial or has a record of noncompliance with medical advice. Taking banned medicine. Life expectancy less than 1 year, may not complete follow-up. Women in pregnancy or lactation, or women with positive pregnancy test. Subjects who are participating in clinical trials of other drugs or devices and have not reached the end point of the trial, or are expected to participate in clinical trials of other drugs or devices. Investigators do not consider it appropriate to participate in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianmin LIU, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

MicroportNT

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201318

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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CATCH [Short Name for: Coil Application Trial in China]

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