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

Last updated: June 26, 2024
Sponsor: Shanghai Wallaby Medical Technologies Co.,Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

pEGASUS Stent System

Clinical Study ID

NCT06158087
TP-1319
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged from 18 to 80 years, male or female;

  • Patients diagnosed as wide-neck intracranial aneurysms by brain CTA/MRA/DSA (neckwidth≥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 stentassisted with coiling;

  • The mRS Score of the patients was 0-2;

  • Patients understand the purpose of the study, accept the follow-up period, and agreeto comply with all requirements, agree to participate in the clinical trial andvoluntarily sign the informed consent.

Exclusion

Exclusion Criteria:

  • Patients who have contraindications to antiplatelet and/or anticoagulant therapy ordo not start antiplatelet therapy in time before treatment.

  • Patients with anatomical structure is not suitable for endovascular treatment due tosevere 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 fromcompleting the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrialfibrillation.

  • Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenousmalformation, intracranial arteriovenous fistula and intracranial hematoma.

  • The target aneurysm has previously received intravascular embolization or stentimplantation 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 duringthe study period;

  • Participation in any other clinical trial within 30 days prior to signing informedconsent;

  • Other conditions considered by the investigator to be inappropriate for enrollment.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: pEGASUS Stent System
Phase:
Study Start date:
December 29, 2023
Estimated Completion Date:
June 20, 2026

Study Description

Title: A prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pEGASUS stent system for assisted endovascular treatment of intracranial aneurysms Device: pEGASUS stent system Design: Prospective, Multicenter, Single Arm Clinical Study. Purpose: To assess safety and effectiveness of the pEGASUS stent system. Study duration: 31 months. Sample Size: 130 patients. Number of sites: ≤10. Follow-up time: 12 months.

Connect with a study center

  • Changhai Hospital

    Shanghai, Shanghai 222018
    China

    Active - Recruiting

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