Aneurysm, IntracranialCOVERNCT02820779
New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
A study testing WILLIS in people with Aneurysm, Intracranial and Carotid-Cavernous Sinus Fistula, run by Xuanwu Hospital, Beijing at 11 sites in China.
Trial summary
The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Intracranial, Carotid-Cavernous Sinus Fistula
- What is being tested?
- WILLIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesChina
- Study dates
- Jun 2016to May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18;
- Arterial wall defects conformed by imaging examination due to internal carotid artery, vertebral artery aneurysms or various causes;
- Target lesion vessel reference diameter 3.5-4.5mm;
- Investigators believe that the patient is suitable for the interventional therapy of WILLIS intracranial covered stent;
- Participate in the study voluntarily, accept follow up study and signed Informed Consent Form.
Who cannot join
- Existence of branch artery (eg anterior choroidal artery, posterior communicating artery, posterior inferior cerebellar artery, etc.) of target lesion which may cause severe neurological dysfunction after occlusion;
- No suitable vessel entrance, or diseased artery extremely tortuous;
- Coagulation disorders or serious heart, liver, kidney dysfunction or systemic infection, which not suitable for interventional treatment;
- Life expectancy <1 year;
- Contraindications to heparin, aspirin, clopidogrel, anesthesia, X-ray or contrast agents;
- Mental disorder
Trial locations and contacts
11 sites in 1 country.
Hongqi Zhang, MD contact
11 sites in 1 country
China11 sites
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
Nanfang hospital, Southern Medical university
Guangzhou, Guangdong, 510515
The 2nd Affiliated Hospital of Harbin Medical university
Harbin, Heilongjiang, 150001
The First Affiliated Hospital of Harbin Medical university
Harbin, Heilongjiang, 150001
Qilu Hospital Of Shang Dong University
Jinan, Shandong, 250012
Shandong Provincial Hospital
Jinan, Shandong, 250021
Tongji Hospital
Shanghai, 200333
ShanXi Provincial People's Hospital
Taiyuan, Shanxi, 030012
The First Affiliated Hospital Of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Tangdu Hospital Fourth Military Medical University
Xi’an, Shanxi, 710038
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.
Read the detailed description
Intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel.WILLIS® intracranial stent graft system is indicated for the treatment of intracranial aneurysms.
This study is a multi-center, prospective registration study.
Recruiting 100 specific patients to undergo a treatment with the WILLIS intracranial stent graft system, while giving the anti-platelet aggregation drugs and other medical therapy.
Patients enrolled will undergo a one-year follow-up.
- Being tested
- WILLIS
- Keywords
- Willis, Intracranial aneurysms
- Medical subject headings
- Intracranial Aneurysm, Carotid-Cavernous Sinus Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WILLISDevice
Also called WILLIS® intracranial stent graft system
WILLIS® intracranial stent graft system is composed of the stent, delivery system, cobalt-based alloy stent and PTFE graft. It can effectively shunt the blood flow and keep it off of the aneurysm wall.
| Study group | Role | What they receive |
|---|---|---|
| WILLIS | Experimental | Patients undergo WILLIS intracranial covered stent interventional treatment Receives: Device: WILLIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year treatment success rate
Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%.
Measured: 12 months
Secondary outcomes (16)
Technically success rate of surgery
Technically success is defined as stent reach the target lesion and successfully released.
Measured: immediately after surgery
Target lesion treatment success rate
Measured: Immediately after surgery
X-ray exposure time
Measured: 24 hours
Operative time
Measured: through surgery completion
Surgery-related complications or death
Measured: 12 months
Various causes of death
Measured: the perioperative period to 12 months
Recurrence of target lesion
Measured: 12 months
Target lesion was treated by interventional or surgical therapy once again
Measured: 12 months
Postoperative ipsilateral symptomatic stroke
Ipsilateral symptomatic stroke is defined as the target lesion is conformed occurs ipsilateral stroke and the increase of NIHSS score point ≥4.
Measured: 30 days; 6 months; 12 months
Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture
Measured: 12 months
Occurs intracranial ischemic stroke that caused by thrombus
Measured: 12 months
All adverse events
Measured: 12 months
Device-related serious adverse events
Measured: 12 months
Target lesion appears stenosis 12 months after surgery
Stenosis is defined as target stenosis ≥50%
Measured: 12 months
Modified Rankin Scale
Measured: 30 days; 6 months; 12 months
NIHSS
Measured: 30 days; 6 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, IntracranialStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Qilu Hospital of Shandong University, Shanghai Tongji Hospital, Tongji University School of Medicine, Nanfang Hospital, Southern Medical University, Tang-Du Hospital, West China Hospital, The First Affiliated Hospital of Zhengzhou University, Shaanxi Provincial People's Hospital, Shandong Provincial Hospital, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Principal investigator, Hongqi Zhang, MD, Xuanwu Hospital, Beijing
- Investigators
- Hongqi Zhang, MD, Principal investigator, hqzh@vip.163.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820779
- Sponsor's protocol ID
- COVER 001
- Acronym
- COVER
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
- ClinicalTrials.gov ID
- NCT02820779
- Acronym / sponsor ID
- COVER / COVER 001
- Keywords
- Willis, Intracranial aneurysms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Qilu Hospital of Shandong University, Shanghai Tongji Hospital, Tongji University School of Medicine, Nanfang Hospital, Southern Medical University, Tang-Du Hospital, West China Hospital, The First Affiliated Hospital of Zhengzhou University, Shaanxi Provincial People's Hospital, Shandong Provincial Hospital, First Affiliated Hospital of Xinjiang Medical University
- Study start
- Jun 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 1 Jul 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 purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.
Detailed description
Intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel.WILLIS® intracranial stent graft system is indicated for the treatment of intracranial aneurysms.
This study is a multi-center, prospective registration study.
Recruiting 100 specific patients to undergo a treatment with the WILLIS intracranial stent graft system, while giving the anti-platelet aggregation drugs and other medical therapy.
Patients enrolled will undergo a one-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WILLIS | Experimental | Device: WILLISPatients undergo WILLIS intracranial covered stent interventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18;
- Arterial wall defects conformed by imaging examination due to internal carotid artery, vertebral artery aneurysms or various causes;
- Target lesion vessel reference diameter 3.5-4.5mm;
- Investigators believe that the patient is suitable for the interventional therapy of WILLIS intracranial covered stent;
- Participate in the study voluntarily, accept follow up study and signed Informed Consent Form.
Key exclusion criteria (6 listed)
- Existence of branch artery (eg anterior choroidal artery, posterior communicating artery, posterior inferior cerebellar artery, etc.) of target lesion which may cause severe neurological dysfunction after occlusion;
- No suitable vessel entrance, or diseased artery extremely tortuous;
- Coagulation disorders or serious heart, liver, kidney dysfunction or systemic infection, which not suitable for interventional treatment;
- Life expectancy <1 year;
- Contraindications to heparin, aspirin, clopidogrel, anesthesia, X-ray or contrast agents;
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 |
|---|---|---|
| WILLISAlso: WILLIS® intracranial stent graft systemWILLIS® intracranial stent graft system is composed of the stent, delivery system, cobalt-based alloy stent and PTFE graft. It can effectively shunt the blood flow and keep it off of the aneurysm wall. | Device | WILLIS |
Primary outcome
1-year treatment success rate
Time frame: 12 months
Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%.
16 secondary outcomes
Technically success rate of surgery
Time frame: immediately after surgery
Target lesion treatment success rate
Time frame: Immediately after surgery
X-ray exposure time
Time frame: 24 hours
Operative time
Time frame: through surgery completion
Surgery-related complications or death
Time frame: 12 months
Various causes of death
Time frame: the perioperative period to 12 months
Recurrence of target lesion
Time frame: 12 months
Target lesion was treated by interventional or surgical therapy once again
Time frame: 12 months
Postoperative ipsilateral symptomatic stroke
Time frame: 30 days; 6 months; 12 months
Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture
Time frame: 12 months
Occurs intracranial ischemic stroke that caused by thrombus
Time frame: 12 months
All adverse events
Time frame: 12 months
Device-related serious adverse events
Time frame: 12 months
Target lesion appears stenosis 12 months after surgery
Time frame: 12 months
Modified Rankin Scale
Time frame: 30 days; 6 months; 12 months
NIHSS
Time frame: 30 days; 6 months; 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- 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.
Hongqi Zhang, MD contact
Hongqi Zhang, MD principal investigator
hqzh@vip.163.com
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WILLIS in people with Aneurysm, Intracranial and Carotid-Cavernous Sinus Fistula, run by Xuanwu Hospital, Beijing at 11 sites 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongqi Zhang, MD (hqzh@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year treatment success rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2016; AzTrials last refreshed its copy on 8 Nov 2026.