Intracranial AneurysmNCT06158087
To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms
A study testing pEGASUS Stent System in people with Intracranial Aneurysm, run by Shanghai Wallaby Medical Technologies Co.,Inc. at 1 site in China.
Trial summary
The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- pEGASUS Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2023to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 222018
Jianmin Liu
About this study
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
The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- pEGASUS Stent System
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pEGASUS Stent SystemDevice
Endovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: pEGASUS Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Rate of major ipsilateral stroke or neurological death
Any major ipsilateral stroke or neurological death
Measured: 12 months
Secondary outcomes (5)
Technical success rate
Technical success is defined as the successful placement of pEGASUS stent system.
Measured: Within 24 hours after surgery
Rate of successful occlusion
Aneurysm successful occlusion is defined as Raymond Grade I/II.
Measured: Within 24 hours after surgery, 6 months, 12 months
Rate of complete occlusion
Aneurysm complete occlusion is defined as Raymond Grade I.
Measured: Within 24 hours after surgery, 6 months, 12 months
Rate of good clinical prognosis
Good clinical prognosis means mRS 0~2
Measured: 3 months, 6 months, 12 months
Death, stroke, and thrombotic events
Record the number of death, stroke and thrombotic events throughout the clinical trial period.
Measured: to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start29 Dec 2023
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Wallaby Medical Technologies Co.,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phenox GmbH, Beijing Wallaby Medical Technologies Co.,Inc.
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158087
- Sponsor's protocol ID
- TP-1319
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06158087
- Acronym / sponsor ID
- TP-1319
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Shanghai Wallaby Medical Technologies Co.,Inc.Industry (pharma, biotech, devices)
- Collaborators
- Phenox GmbH, Beijing Wallaby Medical Technologies Co.,Inc.
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: pEGASUS Stent SystemPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pEGASUS Stent SystemEndovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms | Device | Test group |
Primary outcome
Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography
Time frame: 6 months
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.
Rate of major ipsilateral stroke or neurological death
Time frame: 12 months
Any major ipsilateral stroke or neurological death
5 secondary outcomes
Technical success rate
Time frame: Within 24 hours after surgery
Rate of successful occlusion
Time frame: Within 24 hours after surgery, 6 months, 12 months
Rate of complete occlusion
Time frame: Within 24 hours after surgery, 6 months, 12 months
Rate of good clinical prognosis
Time frame: 3 months, 6 months, 12 months
Death, stroke, and thrombotic events
Time frame: to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Liu principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pEGASUS Stent System in people with Intracranial Aneurysm, run by Shanghai Wallaby Medical Technologies Co.,Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenwen Jia (+86 18818201005, wendy.jia@wallabyphenox.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.