Clinical trial NCT04289480: Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
Official title: ENTERPRISE 2 Vascular Reconstruction Device and Delivery System Registry: A Multicenter, Prospective, Single-arm Observational Study to Evaluate the Safety and Effectiveness With the Device to Facilitate Endovascular Coil Embolization of Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysm
Keywords: intracranial aneurysms, Neurovascular
Lead sponsor: Medos International SARL
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Medical (Shanghai) Ltd.
First posted: 2020-02-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: Incidence of aneurysm recanalization
timeFrame: at 180 days post procedure
Secondary outcomes:
measure: Incidence of aneurysm recanalization
timeFrame: at 1 year post procedure
measure: Successful stent/coil placement rate
timeFrame: immediately post procedure
measure: Aneurysm occlusion
timeFrame: immediately post procedure, at 180 days and at 1 year post procedure
measure: Incidence of retreatment
timeFrame: at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure
Other outcomes:
measure: Incidence of disabling stroke or neurological death
timeFrame: at 180 days, at 1 year post procedure
measure: Incidence of in-stent thrombosis
timeFrame: at 180 days, at 1 year post procedure
measure: Incidence of in-stent stenosis
timeFrame: at 180 days, at 1 year post procedure
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou university
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The first affiliated hospital of Nanchang university
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Huashan Hospital Shanghai Medical college, Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
Study officials:
affiliation: Beijing Tiantan Hospital
name: Xinjian Yang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Shiqing Mu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Qingrong Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital Shanghai Medical college, Fudan University
name: Yuxiang Gu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medical University, China
name: Chuanzhi Duan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Hospital
name: Shu Wan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Bo Yu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Nanchang University
name: Yang Wang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Sheng Guan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
name: Wohua Zhao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Xinjian Yang, Professor
role: PRINCIPAL_INVESTIGATOR
References: