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

Active, not recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Device: ENTERPRISE 2 device

• Registration Number: NCT04289480
• Lead Sponsor: Medos International SARL

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).

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Study Start: 2020-07-30
• Primary Completion: 2022-04-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Study Completion: 2026-09-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 164

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of aneurysm recanalization	at 180 days post procedure	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).

Secondary Outcome Measures

Name	Time	Method
Aneurysm occlusion	immediately post procedure, at 180 days and at 1 year post procedure	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.
Incidence of aneurysm recanalization	at 1 year post procedure	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.
Successful stent/coil placement rate	immediately post procedure	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.
Incidence of retreatment	at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure	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.

Trial Locations

Locations (10)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

The first affiliated hospital of Zhengzhou university; 🇨🇳 Zhengzhou, Henan, China

The first affiliated hospital of Nanchang university; 🇨🇳 Nanchang, Jiangxi, China

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology; 🇨🇳 Wuhan, Hubei, China

Huashan Hospital Shanghai Medical college, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China