Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms

NCT ID: NCT04289480

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2026-09-10

Brief Summary

The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of intracranial aneurysms.

Detailed Description

This is a prospective, multicenter, single-arm observational study, in which enrolled patients will be implanted with the ENTERPRISE 2 for evaluation of safety and effectiveness of ENTERPRISE 2 in real-world applications.

The study population will consist of 164 patients with ruptured or unruptured intracranial aneurysms and a parent vessel diameter of ≥2.5 mm and ≤4 mm. All patients will be implanted with the study device.

The enrolled patients will be followed at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure.

The primary endpoint is the incidence of aneurysm recanalization (at 180 days) evaluated through digital subtraction angiography (DSA). Secondary effectiveness endpoints include incidence of aneurysm recanalization (at 1 year), successful stent/coil placement rate (immediately post procedure), aneurysm occlusion (immediately post procedure, at 180 days and 1 year), incidence of retreatment (at 30 and 180 days, and 1, 2, 3, 4 and 5 years). Safety evaluation include: incidence of disabling stroke or neurological death (at 180 days and 1 year), incidence of in-stent thrombosis (at 180 days and 1 year), and incidence of in-stent stenosis (at 180 days and 1 year). Exploratory endpoints include stent wall apposition performance (intra-procedure), first-time deployment success rate (intra-procedure) and duration of stent deployment (intra-procedure).

Conditions

Intracranial Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ENTERPRISE 2 group

The study population enrolled for this clinical study is "aneurysm patients who need stent-assisted coiling treatment", using ENTERPRISE 2 device.

ENTERPRISE 2 device

Intervention Type: DEVICE

The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.

Interventions

ENTERPRISE 2 device

The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient (or his/her legal representative) understands the nature of the procedure and provides voluntary written informed consent for the use of his/her peri-procedural and follow-up data;

2. Aged between 18 years and 80 years of age the time of consent;

3. Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment;

4. Parent vessel with a diameter of ≥2.5 mm and ≤4 mm;

5. Patient is willing to return to the investigational site for the post-procedure follow-up evaluations.

Exclusion Criteria

1. Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator;

2. Poor clinical condition with modified Rankin Scale (mRS) score ≥4;

3. Having prior or potential severe allergic reaction to contrast medium;

4. Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter;

5. Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e. severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy);

6. Arteriovenous malformation (AVM) in the territory of the target aneurysm;

7. Unsuitable for the antithrombotic and/or anticoagulant therapies;

8. Implantation of an intracranial stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;

9. Implantation of a carotid stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;

10. Evidence of active infection;

11. Pregnant or lactating women;

12. Having participated in clinical studies of other investigational drugs or devices within 30 days prior to signature of Informed Consent Form, excluding epidemiological studies of observational nature or natural history or not involving intervention;

13. Pre-planned staged procedure of target aneurysms.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Medical (Shanghai) Ltd.

INDUSTRY

Sponsor Role: collaborator

Medos International SARL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinjian Yang, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Shiqing Mu, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Qingrong Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Yuxiang Gu, Professor

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital Shanghai Medical college, Fudan University

Chuanzhi Duan, Professor

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Shu Wan, Professor

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Hospital

Bo Yu, Professor

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Yang Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Sheng Guan, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Wohua Zhao, Professor

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

Xinjian Yang, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The first affiliated hospital of Nanchang university

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Huashan Hospital Shanghai Medical college, Fudan University

Shanghai, Shanghai Municipality, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CNV_2018_02

Identifier Type: -

Identifier Source: org_study_id