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NCT06158087 | RECRUITING | Intracranial Aneurysm

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

Shanghai Wallaby Medical Technologies Co.,Inc.

Brief Summary:

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

Condition or disease

Intracranial Aneurysm

Intervention/treatment

pEGASUS Stent System

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of pEGASUS Stent System for Assisted Endovascular Treatment of Intracranial Aneurysms
Actual Study Start Date : 2023-12-29
Estimated Primary Completion Date : 2026-02-20
Estimated Study Completion Date : 2026-06-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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.
To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms

Location Details

NCT06158087

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Shanghai

Changhai Hospital

Shanghai, Shanghai, China, 222018