To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms

NCT06158087 | Recruiting

• 1 other identifier: TP-1319
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography

  Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 6 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.

  6 months

• Rate of major ipsilateral stroke or neurological death

  Any major ipsilateral stroke or neurological death

  12 months

Secondary Outcomes (5)

• Technical success rate

  Within 24 hours after surgery

• Rate of successful occlusion

  Within 24 hours after surgery, 6 months, 12 months

• Rate of complete occlusion

  Within 24 hours after surgery, 6 months, 12 months

• Rate of good clinical prognosis

  3 months, 6 months, 12 months

• Death, stroke, and thrombotic events

  to 12 months

Study Arms (1)

Test group

EXPERIMENTAL

Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use pEGASUS stent system assisted to treat intracranial aneurysm.

Device: pEGASUS Stent System

Interventions

pEGASUS Stent System DEVICE

Endovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms

Test group

Eligibility Criteria

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

You may qualify if:

• Aged from 18 to 80 years, male or female;
• Patients diagnosed as wide-neck intracranial aneurysms by brain CTA/MRA/DSA (neck width≥4mm or bodyor a dome-to-neck ratio\<2);
• Parent vessel with a diameter of ≥2.5mm and ≤4.5mm;
• Patients target aneurysm is planned to be embolized using intracranial stent assisted with coiling;
• The mRS Score of the patients was 0-2;
• Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.

You may not qualify if:

• Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment.
• Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography.
• Known to be allergic to Nitinol platinum alloy and angiographic agents.
• Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation.
• Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenous malformation, intracranial arteriovenous fistula and intracranial hematoma.
• The target aneurysm has previously received intravascular embolization or stent implantation treatment;
• Multiple aneurysms or complex aneurysms;
• Patients with acute ruptured aneurysm;
• Serious infection is not controlled and is not suitable for operation;
• Patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery;
• Obvious abnormal coagulation function or bleeding tendency;
• Combined with severe renal insufficiency, creatinine greater than or equal to 200umol/L; Patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or ALT more than 3 times the upper normal limit;
• Pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period;
• Participation in any other clinical trial within 30 days prior to signing informed consent;
• Other conditions considered by the investigator to be inappropriate for enrollment.

Sponsors & Collaborators

• Shanghai Wallaby Medical Technologies Co.,Inc.: lead
• Phenox GmbH: collaborator
• Beijing Wallaby Medical Technologies Co.,Inc.: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 222018, China

RECRUITING

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

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenwen Jia

CONTACT

+86 18818201005; wendy.jia@wallabyphenox.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 6, 2023
• Study Start: December 29, 2023
• Primary Completion: February 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: June 27, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)