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

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.

Study Overview

• Status: Unknown
• Conditions: Aneurysm, Intracranial; Carotid-Cavernous Sinus Fistula
• Intervention / Treatment: Device: WILLIS

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongqi Zhang, MD; Email: hqzh@vip.163.com

Study Locations

• China
  • Shanghai, China, 200333
    • Tongji Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The 2nd Affiliated Hospital Of Harbin Medical University
    • Harbin, Heilongjiang, China, 150001
      • The First Affiliated Hospital Of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • First Affiliated Hospital of Zhengzhou University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
    • Jinan, Shandong, China, 250012
      • Qilu Hospital Of Shang Dong University
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Shanxi Provincial People's Hospital
    • Xi'an, Shanxi, China, 710038
      • Tangdu Hospital Fourth Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital Sichuan University
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WILLIS; Patients undergo WILLIS intracranial covered stent interventional treatment	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.; Other Names: WILLIS® intracranial stent graft system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technically success rate of surgery	Technically success is defined as stent reach the target lesion and successfully released.	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
Various causes of death		the perioperative period to 12 months
Recurrence of target lesion		12 months
Target lesion was treated by interventional or surgical therapy once again		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.	30 days; 6 months; 12 months
Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture		12 months
Occurs intracranial ischemic stroke that caused by thrombus		12 months
All adverse events		12 months
Device-related serious adverse events		12 months
Target lesion appears stenosis 12 months after surgery	Stenosis is defined as target stenosis ≥50%	12 months
Modified Rankin Scale		30 days; 6 months; 12 months
NIHSS		30 days; 6 months; 12 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: West China Hospital; Qilu Hospital of Shandong University; Nanfang Hospital of Southern Medical University; Shandong Provincial Hospital; The First Affiliated Hospital of Zhengzhou University; Shaanxi Provincial People's Hospital; Tang-Du Hospital; The Second Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Xinjiang Medical University; Shanghai Tongji Hospital, Tongji University School of Medicine; First Affiliated Hospital of Harbin Medical University
• Investigators: Principal Investigator: Hongqi Zhang, MD, hqzh@vip.163.com

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Willis; Intracranial aneurysms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Congenital Abnormalities; Pathological Conditions, Anatomical; Trauma, Nervous System; Carotid Artery Diseases; Cardiovascular Abnormalities; Vascular Malformations; Intracranial Arterial Diseases; Arteriovenous Malformations; Vascular Fistula; Carotid Artery Injuries; Cerebrovascular Trauma; Arteriovenous Fistula; Fistula; Aneurysm; Intracranial Aneurysm; Carotid-Cavernous Sinus Fistula
• Other Study ID Numbers: COVER 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No