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

NCT02820779 | Unknown

• 1 other identifier: COVER 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Aneurysm, Intracranial; Carotid-Cavernous Sinus Fistula

Keywords

Willis; Intracranial aneurysms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Technically success rate of surgery

  immediately after surgery

• Target lesion treatment success rate

  Immediately after surgery

• X-ray exposure time

  24 hours

• Operative time

  through surgery completion

• Surgery-related complications or death

  12 months

Study Arms (1)

WILLIS

EXPERIMENTAL

Patients undergo WILLIS intracranial covered stent interventional treatment

Device: WILLIS

Interventions

WILLIS DEVICE

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.

Also known as: WILLIS® intracranial stent graft system

WILLIS

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (11)

Nanfang hospital, Southern Medical university

Guangzhou, Guangdong, 510515, China

Location

The 2nd Affiliated Hospital of Harbin Medical university

Harbin, Heilongjiang, 150001, China

Location

The First Affiliated Hospital of Harbin Medical university

Harbin, Heilongjiang, 150001, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Qilu Hospital Of Shang Dong University

Jinan, Shandong, 250012, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

ShanXi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

Tangdu Hospital Fourth Military Medical University

Xi’an, Shanxi, 710038, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital Of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Tongji Hospital

Shanghai, 200333, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Carotid-Cavernous Sinus Fistula

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Cavernous Sinus Syndromes; Carotid Artery Diseases; Carotid Artery Injuries; Cerebrovascular Trauma; Trauma, Nervous System; Arteriovenous Fistula; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Fistula; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Hongqi Zhang, MD

  hqzh@vip.163.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongqi Zhang, MD

CONTACT

hqzh@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cerebrovascular Expert Committee of Chinese Medical Doctor Association

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 1, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

CN (11)