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

NCT04289480 | Active Not Recruiting FDA Device

• 1 other identifier: CNV_2018_02
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 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.

Conditions

Intracranial Aneurysm

Keywords

intracranial aneurysms, Neurovascular

Outcome Measures

Primary Outcomes (1)

• Incidence of aneurysm recanalization

  Incidence of aneurysm recanalization (at 180 days) = number of target aneurysm recanalization (at 180 days) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 180-day follow-up will be obtained through DSA, and the post-procedure immediate aneurysm recanalization shown in angiograms will be graded as per the Raymond-Roy Classification Scale. The Raymond-Roy Classification at each follow-up time point increased by ≥ one class relative to that immediately after the procedure is defined as recanalization (e.g., Class I immediately after the procedure, Class II at 180-day follow-up).

  at 180 days post procedure

Secondary Outcomes (4)

• Incidence of aneurysm recanalization

  at 1 year post procedure

• Successful stent/coil placement rate

  immediately post procedure

• Aneurysm occlusion

  immediately post procedure, at 180 days and at 1 year post procedure

• Incidence of retreatment

  at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure

Other Outcomes (3)

• Incidence of disabling stroke or neurological death

  at 180 days, at 1 year post procedure

• Incidence of in-stent thrombosis

  at 180 days, at 1 year post procedure

• Incidence of in-stent stenosis

  at 180 days, at 1 year post procedure

Study Arms (1)

ENTERPRISE 2 group

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

Device: ENTERPRISE 2 device

Interventions

ENTERPRISE 2 device DEVICE

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

ENTERPRISE 2 group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will be conducted in patients with unruptured or ruptured intracranial aneurysm with a parent vessel diameter of ≥2.5 mm and ≤4 mm.

You may qualify if:

• 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;
• Aged between 18 years and 80 years of age the time of consent;
• Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment;
• Parent vessel with a diameter of ≥2.5 mm and ≤4 mm;
• Patient is willing to return to the investigational site for the post-procedure follow-up evaluations.

You may not qualify if:

• Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator;
• Poor clinical condition with modified Rankin Scale (mRS) score ≥4;
• Having prior or potential severe allergic reaction to contrast medium;
• Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter;
• 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);
• Arteriovenous malformation (AVM) in the territory of the target aneurysm;
• Unsuitable for the antithrombotic and/or anticoagulant therapies;
• Implantation of an intracranial stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
• Implantation of a carotid stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
• Evidence of active infection;
• Pregnant or lactating women;
• 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;
• Pre-planned staged procedure of target aneurysms.

Sponsors & Collaborators

• Medos International SARL: lead
• Johnson & Johnson Medical (Shanghai) Ltd.: collaborator

Study Sites (10)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, 450052, China

Location

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

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

The first affiliated hospital of Nanchang university

Nanchang, Jiangxi, 330006, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Huashan Hospital Shanghai Medical college, Fudan University

Shanghai, Shanghai Municipality, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, 310007, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xinjian Yang, Professor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Shiqing Mu, Professor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Qingrong Zhang, Professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

• Yuxiang Gu, Professor

  Huashan Hospital Shanghai Medical college, Fudan University

  PRINCIPAL INVESTIGATOR

• Chuanzhi Duan, Professor

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

• Shu Wan, Professor

  Zhejiang Hospital

  PRINCIPAL INVESTIGATOR

• Bo Yu, Professor

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Yang Wang, Professor

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Sheng Guan, Professor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Wohua Zhao, Professor

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

  PRINCIPAL INVESTIGATOR

• Xinjian Yang, Professor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: February 28, 2020
• Study Start: July 30, 2020
• Primary Completion: April 22, 2022
• Study Completion (Estimated): September 10, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (10)