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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: ENTERPRISE 2 device

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).

• Study Type: Observational
• Enrollment (Estimated): 164

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Zhujiang hospital of southern medical university
  • Henan
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital Shanghai Medical college, Fudan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310007
      • Zhejiang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of aneurysm recanalization	Incidence of aneurysm recanalization (at 1 year) = number of target aneurysm recanalization (at 1 year) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 1 year follow-ups will be obtained through DSA or MRA or CTA.	at 1 year post procedure
Successful stent/coil placement rate	Successful stent/coil placement rate = number of target aneurysms with successful stent/coil placement ÷ total number of target aneurysms× 100%. Successful stent/coil placement is defined as successful stent deployment and successful delivery and placement of the coil at the target aneurysm assessed immediately post procedure through angiography.	immediately post procedure
Aneurysm occlusion	Aneurysm occlusion rate = number of target aneurysms with Raymond-Roy Class I or II aneurysm occlusion÷ total number of target aneurysms× 100%. The aneurysm occlusion will be assessed by classifying the post-procedure immediate aneurysm occlusion shown in angiograms based on the Raymond-Roy Classification.	immediately post procedure, at 180 days and at 1 year post procedure
Incidence of retreatment	Incidence of retreatment = number of target aneurysms receiving retreatment during the follow-up ÷ total number of target aneurysms receiving follow-up ×100%. Retreatment refers to any intervention to the target aneurysm after completing first stent-assisted coil embolization for the target aneurysm.	at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of disabling stroke or neurological death	Incidence of disabling stroke or neurological death = number of patients with disabling stroke or neurological death ÷ total number of patients receiving follow-up × 100%. Stroke is defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke or hemorrhagic stroke (i.e., intraparenchymal hemorrhage (IPH), SAH, subdural hemorrhage (SDH), epidural hemorrhage (EDH)). Disabling stroke is defined as mRS score ≥ 3 assessed at a minimum of 90 days (+/- 30 days) post-stroke event. Neurological death, also called brain death, refers to irreversible loss of the capacity for consciousness combined with the irreversible loss of all brainstem functions, including the capacity to breathe.	at 180 days, at 1 year post procedure
Incidence of in-stent thrombosis	Incidence of in-stent thrombosis = number of target aneurysms with parent vessel (in-stent) thrombosis during follow-up ÷ total number of target aneurysms receiving follow-up ×100%.	at 180 days, at 1 year post procedure
Incidence of in-stent stenosis	Incidence of in-stent stenosis = number of target aneurysms with parent vessel (in-stent) stenosis during follow-up ÷ total number of target aneurysms receiving follow-up ×100%. Mild, moderate, and severe in-stent stenosis is clinically defined as a stenosis of <33%, 33-67%, and ≥67%, respectively, comparing with non-stented parent vessel [43, 44]. In this study, moderate and severe in-stent stenoses (with a stenosis of ≥33%) of the parent vessel are defined as in-stent stenosis.	at 180 days, at 1 year post procedure

Collaborators and Investigators

• Sponsor: Medos International SARL
• Collaborators: Johnson & Johnson Medical (Shanghai) Ltd.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): April 22, 2022
• Study Completion (Estimated): January 26, 2027

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: intracranial aneurysms, Neurovascular
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CNV_2018_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes