## Protocol Section
### Identification Module
**NCT ID:** NCT02820779

**Acronym:** COVER

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

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

#### Organization Study ID Info
**ID:** COVER 001
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2019-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2016-07-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-06-28

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-06

**Status Verified Date:** 2016-06

#### Study First Post Date
**Date:** 2016-07-01
**Type:** ESTIMATED
**Study First Submit Date:** 2016-06-23
**Study First Submit QC Date:** 2016-06-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** First Affiliated Hospital of Harbin Medical University

**Class:** OTHER

**Name:** The Second Affiliated Hospital of Harbin Medical University

**Class:** OTHER

**Name:** Qilu Hospital of Shandong University

**Class:** OTHER

**Name:** Shanghai Tongji Hospital, Tongji University School of Medicine

**Class:** OTHER

**Name:** Nanfang Hospital, Southern Medical University

**Class:** OTHER

**Name:** Tang-Du Hospital

**Class:** OTHER

**Name:** West China Hospital

**Class:** OTHER

**Name:** The First Affiliated Hospital of Zhengzhou University

**Class:** OTHER

**Name:** Shaanxi Provincial People's Hospital

**Class:** OTHER_GOV

**Name:** Shandong Provincial Hospital

**Class:** OTHER

**Name:** First Affiliated Hospital of Xinjiang Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** Xuanwu Hospital, Beijing

#### Responsible Party

**Investigator Affiliation:** Xuanwu Hospital, Beijing

**Investigator Full Name:** Hongqi Zhang, MD

**Investigator Title:** Cerebrovascular Expert Committee of Chinese Medical Doctor Association

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Aneurysm, Intracranial

- Carotid-Cavernous Sinus Fistula

**Keywords:**

- Willis

- Intracranial aneurysms

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients undergo WILLIS intracranial covered stent interventional treatment

**Intervention Names:**

- Device: WILLIS

**Label:** WILLIS

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- WILLIS

**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.

**Name:** WILLIS

**Other Names:**

- WILLIS® intracranial stent graft system

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**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%.

**Measure:** 1-year treatment success rate

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Technically success is defined as stent reach the target lesion and successfully released.

**Measure:** Technically success rate of surgery

**Time Frame:** immediately after surgery

**Measure:** Target lesion treatment success rate

**Time Frame:** Immediately after surgery

**Measure:** X-ray exposure time

**Time Frame:** 24 hours

**Measure:** Operative time

**Time Frame:** through surgery completion

**Measure:** Surgery-related complications or death

**Time Frame:** 12 months

**Measure:** Various causes of death

**Time Frame:** the perioperative period to 12 months

**Measure:** Recurrence of target lesion

**Time Frame:** 12 months

**Measure:** Target lesion was treated by interventional or surgical therapy once again

**Time Frame:** 12 months

**Description:** Ipsilateral symptomatic stroke is defined as the target lesion is conformed occurs ipsilateral stroke and the increase of NIHSS score point ≥4.

**Measure:** Postoperative ipsilateral symptomatic stroke

**Time Frame:** 30 days; 6 months; 12 months

**Measure:** Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture

**Time Frame:** 12 months

**Measure:** Occurs intracranial ischemic stroke that caused by thrombus

**Time Frame:** 12 months

**Measure:** All adverse events

**Time Frame:** 12 months

**Measure:** Device-related serious adverse events

**Time Frame:** 12 months

**Description:** Stenosis is defined as target stenosis ≥50%

**Measure:** Target lesion appears stenosis 12 months after surgery

**Time Frame:** 12 months

**Measure:** Modified Rankin Scale

**Time Frame:** 30 days; 6 months; 12 months

**Measure:** NIHSS

**Time Frame:** 30 days; 6 months; 12 months

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hqzh@vip.163.com

**Name:** Hongqi Zhang, MD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Nanfang hospital, Southern Medical university

**State:** Guangdong

**Zip:** 510515

**Location 2:**

**City:** Harbin

**Country:** China

**Facility:** The 2nd Affiliated Hospital of Harbin Medical university

**State:** Heilongjiang

**Zip:** 150001

**Location 3:**

**City:** Harbin

**Country:** China

**Facility:** The First Affiliated Hospital of Harbin Medical university

**State:** Heilongjiang

**Zip:** 150001

**Location 4:**

**City:** Zhengzhou

**Country:** China

**Facility:** First Affiliated Hospital of Zhengzhou University

**State:** Henan

**Zip:** 450052

**Location 5:**

**City:** Jinan

**Country:** China

**Facility:** Qilu Hospital Of Shang Dong University

**State:** Shandong

**Zip:** 250012

**Location 6:**

**City:** Jinan

**Country:** China

**Facility:** Shandong Provincial Hospital

**State:** Shandong

**Zip:** 250021

**Location 7:**

**City:** Taiyuan

**Country:** China

**Facility:** ShanXi Provincial People's Hospital

**State:** Shanxi

**Zip:** 030012

**Location 8:**

**City:** Xi'an

**Country:** China

**Facility:** Tangdu Hospital Fourth Military Medical University

**State:** Shanxi

**Zip:** 710038

**Location 9:**

**City:** Chengdu

**Country:** China

**Facility:** West China Hospital Sichuan University

**State:** Sichuan

**Zip:** 610041

**Location 10:**

**City:** Urumqi

**Country:** China

**Facility:** The First Affiliated Hospital Of Xinjiang Medical University

**State:** Xinjiang

**Zip:** 830054

**Location 11:**

**City:** Shanghai

**Country:** China

**Facility:** Tongji Hospital

**Zip:** 200333

#### Overall Officials

**Official 1:**

**Affiliation:** hqzh@vip.163.com

**Name:** Hongqi Zhang, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000020765

- Term: Intracranial Arterial Diseases

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000096826

- Term: Cavernous Sinus Syndromes

- ID: D000002340

- Term: Carotid Artery Diseases

- ID: D000020212

- Term: Carotid Artery Injuries

- ID: D000020214

- Term: Cerebrovascular Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000001164

- Term: Arteriovenous Fistula

- ID: D000001165

- Term: Arteriovenous Malformations

- ID: D000054079

- Term: Vascular Malformations

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000016157

- Term: Vascular Fistula

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M5781

- Name: Intracranial Aneurysm

- Relevance: HIGH

- As Found: Aneurysm, Intracranial

- ID: M4113

- Name: Aneurysm

- Relevance: HIGH

- As Found: Aneurysm

- ID: M22042

- Name: Carotid-Cavernous Sinus Fistula

- Relevance: HIGH

- As Found: Carotid-Cavernous Sinus Fistula

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M22521

- Name: Intracranial Arterial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M5594

- Name: Carotid Artery Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22039

- Name: Carotid Artery Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M22040

- Name: Cerebrovascular Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M4472

- Name: Arteriovenous Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M4473

- Name: Arteriovenous Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M27558

- Name: Vascular Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M18619

- Name: Vascular Fistula

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002532

- Term: Intracranial Aneurysm

- ID: D000020216

- Term: Carotid-Cavernous Sinus Fistula

- ID: D000000783

- Term: Aneurysm

- ID: D000005402

- Term: Fistula

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6265

- Name: Cobalt

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
