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

NCT02990156 | Completed

• 1 other identifier: 2016-Nemo-01-A
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Keywords

Coils

Outcome Measures

Primary Outcomes (1)

• 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).

  6 Months

Secondary Outcomes (1)

• Modified Rankin Scale

  6 Months

Study Arms (2)

Coil Embolization System

EXPERIMENTAL

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.

Device: Coil Embolization System

Control device from Medronic

ACTIVE COMPARATOR

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

Device: Cotrol device from Medronic

Interventions

Coil Embolization System DEVICE

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.

Coil Embolization System

Cotrol device from Medronic DEVICE

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

Control device from Medronic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (1)

MicroportNT

Shanghai, Shanghai Municipality, 201318, China

Location

Related Publications (1)

• Jin Y, Guo X, Quan T, Zhao R, Li T, Zhao Z, Yang H, Zhu X, Liang G, Leng B, Wu X, Wang Y, Guan S. Randomized, prospective, multicenter trial assessing the numen coil embolization system in the endovascular treatment of small intracranial aneurysms: outcomes from the CATCH Trial. BMC Surg. 2023 Jun 16;23(1):164. doi: 10.1186/s12893-023-02049-9.

  PMID: 37328839 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin LIU, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 13, 2016
• Study Start: August 8, 2017
• Primary Completion: March 25, 2019
• Study Completion: November 21, 2020
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CN (1)