Intracranial AneurysmCATCHNCT02990156
CATCH [Short Name for: Coil Application Trial in China]
A study testing Coil Embolization System and Cotrol device from Medronic in people with Intracranial Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Coil Embolization System and Cotrol device from Medronic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2017to 21 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Coil Embolization System, Cotrol device from Medronic
- Keywords
- Coils
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coil Embolization SystemDevice
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.
Cotrol device from MedronicDevice
Control device from Medronic (include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils) are manufactured by ev3 (Medtronic, Irvine, California, USA);
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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); Receives: Device: Cotrol device from Medronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 Months
Secondary outcomes (1)
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start8 Aug 2017
- Primary completion25 Mar 2019
- Study completion21 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin LIU, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990156
- Sponsor's protocol ID
- 2016-Nemo-01-A
- Acronym
- CATCH
- Status last verified
- Apr 2022
- First submitted
- 1 Dec 2016
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37328839
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02990156
- Acronym / sponsor ID
- CATCH / 2016-Nemo-01-A
- Conditions
- Intracranial Aneurysm
- Keywords
- Coils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coil Embolization System | Experimental | Device: Coil Embolization SystemCoil 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 | Active comparator | Device: Cotrol device from MedronicControl device from Medronic,include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils, which are manufactured by ev3 (Medtronic, Irvine, California, USA); |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coil Embolization Systemdeposits 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. | Device | Coil Embolization System |
| Cotrol device from MedronicControl device from Medronic (include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils) are manufactured by ev3 (Medtronic, Irvine, California, USA); | Device | Control device from Medronic |
Primary outcome
Raymond Scale
Time frame: 6 Months
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).
1 secondary outcome
Modified Rankin Scale
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 37328839Jin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin LIU, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil Embolization System and Cotrol device from Medronic in people with Intracranial Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raymond Scale (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02990156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.