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

Primary Purpose

Aneurysm, Intracranial, Carotid-Cavernous Sinus Fistula

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WILLIS
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm, Intracranial focused on measuring Willis, Intracranial aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanfang hospital, Southern Medical university
  • The 2nd Affiliated Hospital of Harbin Medical university
  • The First Affiliated Hospital of Harbin Medical university
  • First Affiliated Hospital of Zhengzhou University
  • Qilu Hospital Of Shang Dong University
  • Shandong Provincial Hospital
  • ShanXi Provincial People's Hospital
  • Tangdu Hospital Fourth Military Medical University
  • West China Hospital Sichuan University
  • The First Affiliated Hospital Of Xinjiang Medical University
  • Tongji Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WILLIS

Arm Description

Patients undergo WILLIS intracranial covered stent interventional treatment

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Technically success rate of surgery
Technically success is defined as stent reach the target lesion and successfully released.
Target lesion treatment success rate
X-ray exposure time
Operative time
Surgery-related complications or death
Various causes of death
Recurrence of target lesion
Target lesion was treated by interventional or surgical therapy once again
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.
Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture
Occurs intracranial ischemic stroke that caused by thrombus
All adverse events
Device-related serious adverse events
Target lesion appears stenosis 12 months after surgery
Stenosis is defined as target stenosis ≥50%
Modified Rankin Scale
NIHSS

Full Information

First Posted
June 23, 2016
Last Updated
June 28, 2016
Sponsor
Xuanwu Hospital, Beijing
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
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1. Study Identification

Unique Protocol Identification Number
NCT02820779
Brief Title
New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
Acronym
COVER
Official Title
New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm, Intracranial, Carotid-Cavernous Sinus Fistula
Keywords
Willis, Intracranial aneurysms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WILLIS
Arm Type
Experimental
Arm Description
Patients undergo WILLIS intracranial covered stent interventional treatment
Intervention Type
Device
Intervention Name(s)
WILLIS
Other Intervention Name(s)
WILLIS® intracranial stent graft system
Intervention Description
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.
Primary Outcome Measure Information:
Title
1-year treatment success rate
Description
Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technically success rate of surgery
Description
Technically success is defined as stent reach the target lesion and successfully released.
Time Frame
immediately after surgery
Title
Target lesion treatment success rate
Time Frame
Immediately after surgery
Title
X-ray exposure time
Time Frame
24 hours
Title
Operative time
Time Frame
through surgery completion
Title
Surgery-related complications or death
Time Frame
12 months
Title
Various causes of death
Time Frame
the perioperative period to 12 months
Title
Recurrence of target lesion
Time Frame
12 months
Title
Target lesion was treated by interventional or surgical therapy once again
Time Frame
12 months
Title
Postoperative ipsilateral symptomatic stroke
Description
Ipsilateral symptomatic stroke is defined as the target lesion is conformed occurs ipsilateral stroke and the increase of NIHSS score point ≥4.
Time Frame
30 days; 6 months; 12 months
Title
Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture
Time Frame
12 months
Title
Occurs intracranial ischemic stroke that caused by thrombus
Time Frame
12 months
Title
All adverse events
Time Frame
12 months
Title
Device-related serious adverse events
Time Frame
12 months
Title
Target lesion appears stenosis 12 months after surgery
Description
Stenosis is defined as target stenosis ≥50%
Time Frame
12 months
Title
Modified Rankin Scale
Time Frame
30 days; 6 months; 12 months
Title
NIHSS
Time Frame
30 days; 6 months; 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongqi Zhang, MD
Email
hqzh@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongqi Zhang, MD
Organizational Affiliation
hqzh@vip.163.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang hospital, Southern Medical university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The 2nd Affiliated Hospital of Harbin Medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Qilu Hospital Of Shang Dong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
ShanXi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030012
Country
China
Facility Name
Tangdu Hospital Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital Of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Tongji Hospital
City
Shanghai
ZIP/Postal Code
200333
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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