New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

Aneurysm, Intracranial Clinical Trial

— COVER  

Official title:

New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02820779
• Other study ID #: COVER 001
• Status: Not yet recruiting
• Phase: N/A
• First received: June 23, 2016
• Last updated: June 28, 2016
• Start date: June 2016
• Est. completion date: May 2019

Study information

• Verified date: June 2016
• Source: Xuanwu Hospital, Beijing
• Contact: Hongqi Zhang, MD
• Email: hqzh[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm, Intracranial
• Carotid-Cavernous Sinus Fistula
• Intracranial Aneurysm

Intervention

Device:
• WILLIS
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.

Locations

Country	Name	City	State
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Nanfang hospital, Southern Medical university	Guangzhou	Guangdong
China	The 2nd Affiliated Hospital of Harbin Medical university	Harbin	Heilongjiang
China	The First Affiliated Hospital of Harbin Medical university	Harbin	Heilongjiang
China	Qilu Hospital Of Shang Dong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Tongji Hospital	Shanghai
China	ShanXi Provincial People's Hospital	Taiyuan	Shanxi
China	The First Affiliated Hospital Of Xinjiang Medical University	Urumqi	Xinjiang
China	Tangdu Hospital Fourth Military Medical University	Xi'an	Shanxi
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (12)

Lead Sponsor

Collaborator

Xuanwu Hospital, Beijing

First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, Nanfang Hospital of Southern Medical University, Qilu Hospital, Shaanxi Provincial People's Hospital, Shandong Provincial Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Tang-Du Hospital, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Harbin Medical University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	12 months	Yes
Secondary	Technically success rate of surgery	Technically success is defined as stent reach the target lesion and successfully released.	immediately after surgery	No
Secondary	Target lesion treatment success rate		Immediately after surgery	No
Secondary	X-ray exposure time		24 hours	Yes
Secondary	Operative time		through surgery completion	Yes
Secondary	Surgery-related complications or death		12 months	Yes
Secondary	Various causes of death		the perioperative period to 12 months	Yes
Secondary	Recurrence of target lesion		12 months	No
Secondary	Target lesion was treated by interventional or surgical therapy once again		12 months	Yes
Secondary	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.	30 days; 6 months; 12 months	Yes
Secondary	Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture		12 months	Yes
Secondary	Occurs intracranial ischemic stroke that caused by thrombus		12 months	Yes
Secondary	All adverse events		12 months	Yes
Secondary	Device-related serious adverse events		12 months	Yes
Secondary	Target lesion appears stenosis 12 months after surgery	Stenosis is defined as target stenosis =50%	12 months	No
Secondary	Modified Rankin Scale		30 days; 6 months; 12 months	No
Secondary	NIHSS		30 days; 6 months; 12 months	No