Efficacy, SelfNCT06446778
Pipeline Embolization for Intracranial Aneurysms
An observational study of Efficacy, Self and Hemodynamic Instability, run by Zhujiang Hospital at 1 site in China.
Trial summary
This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Efficacy, Self, Hemodynamic Instability, Stenosis
- What is being tested?
- Pipeline embolization device with or without shield technique
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent Pipeline implantation for intracranial aneurysms
Who may be able to join
- Aged 22 to 75 years old, male or non-pregnant female;
- UIA was diagnosed by CTA, MRA, or DSA;
- The size of aneurysms is between 3 to 25mm;
- Understands the nature of the procedure and provision of written informed consent;
- Indications for FD implantation with or without adjunctive coiling;
- Is willing to return to the investigational site for follow-up according to our protocol.
Who cannot join
- With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium;
- Pregnancy or lactation;
- Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);
- Parent vessel with a diameter <2.0 mm or ≥5.0 mm.;
- Unwilling to be followed up or likely to have poor treatment compliance;
- Life expectancy less than 3 years;
Show all 9Show fewer
- Inability to receive anti-platelet or anticoagulant medication;
- Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);
- Enrollment in another trial or other situations that the researcher deems unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang hospital
Guangzhou, Guangdong
Chuanzhi Duan, 020-62782757, doctor_duanzj@163.com
Xin Feng, MD
About this study
Official title: Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics
This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization.
Read the detailed description
This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization. The primary outcomes were aneurysmal occlusion status, incidence of in-stent stenosis, and functional prognosis. The secondary outcomes were hemodynamic changes before and after stent implantation.
- Being tested
- Pipeline embolization device with or without shield technique
- Keywords
- intracranial aneurysms, flow-diverter device, Pipeline embolization device, in-stent stenosis
- Medical subject headings
- Constriction, Pathologic, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipeline embolization device with or without shield techniqueDevice
The patients undenwent Pipeline embolization device implantation with or without shield technique due to market availability, choice and preferences of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Saccular aneurysms | Patients with saccular aneurysms were enrolled. Receives: Device: Pipeline embolization device with or without shield technique | |
| Non-saccular aneurysms | Patients with non-saccular (i.e., fusiform, dissecting, blood blister-like) aneurysms were enrolled. Receives: Device: Pipeline embolization device with or without shield technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occlusion rate of the aneurysm
The occlusion rate of the aneurysm at 6 months；O'Kelly Marotta classification: complete occlusion (D, entirely non-filling), near-complete occlusion (C, only entry remnant), and incomplete occlusion (A and B, subtotal and total filling).
Measured: 1 years
Secondary outcomes (2)
in-stent stenosis
In-stent stenosis is defined as a growth process beyond the limits of stent mesh, which appears as a visible gap between the vessel lumen filled with contrast agent and stent struts.
Stenosis ratio (SR) = [1-(actual diameter of the most stenotic segment with digital subtraction/actual diameter of stent measured on without digital subtraction)]*100%
When there was no appreciable gap, cases were described as patency. Intimal hyperplasia was labeled when the SR was less than 25 %. ISS was defined as an SR of ≥ 25 %, and the stenosis grade was classified as mild (25 % to 49 %), severe (50 % to 99 %), or lumen occlusion (SR = 100 %)
Measured: 1 years
perioperative complications
perioperative complications；such as arterial perforation, iatrogenic arterial dissection, embolization in previously uninvolved vascular territory, arterial access site hematoma, and retroperitoneal hematoma. Arterial perforation will be defined at angiography by the operator and associated with subarachnoid hemorrhage. Iatrogenic arterial dissection will be defined at angiography by the operator. Arterial access site hematoma will be assessed as a complication of arterial access puncture and defined by clinical examination and anatomic imaging. Retroperitoneal hematoma will be assessed as a complication of groin puncture and defined by imaging (ultrasound or CT or MR angiography). The definition of embolization in previously uninvolved vascular territory is noted after recanalization of the primary occlusion site, any vessel occlusions distal from the primary occlusion site are considered emboli due to periprocedural thrombus fragmentation.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Sep 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Efficacy, SelfStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Eighth Affiliated Hospital, Sun Yat-sen University, Zhongshan Hospital Of Traditional Chinese Medicine, First Affiliated Hospital of Jinan University, Beijing Tiantan Hospital, First Affiliated Hospital of Chongqing Medical University, Affiliated Hospital of Southwest Medical University, Guangdong 999 Brain Hospital, Shantou Central Hospital, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Harbin Medical University
- Responsible party
- Sponsor
- Investigators
- Chuanzhi Duan, MD, Study director, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446778
- Sponsor's protocol ID
- LC2024ZD027
- Status last verified
- Nov 2024
- First submitted
- 22 May 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided
Publications
Ge R, Peng C, Chen W, Chen G, Li C, Guan P, Dai L, Wen Z, Huang C, Huang J, Lin J, Huang M, Yuan H, Yuan F, Wang Y, Bi Y, Su S, Zhang X, Li X, Liu A, Liang S, Duan C, Feng X. Pipeline Shield versus Pipeline Flex for unruptured intracranial aneurysms: a propensity-matched multicenter study. Neuroradiology. 2026 Sep 19. doi: 10.1007/s00234-026-04186-3. Online ahead of print.
PubMed 42760406Huang C, Zhu Y, Feng X, Tong X, Wen Z, Lin J, Huang M, Yuan H, Dai L, Chen W, Hu Y, Bi Y, Deng X, Xie Z, Shang G, Luo Y, Zhao Y, Peng C, Huang C, Su S, Zhang X, Li X, Guo Z, Liu A, Duan C. Stent match of pipeline embolization device: prediction of incomplete occlusion and in-stent stenosis by actual stent size after implantation. Neurosurg Rev. 2025 May 30;48(1):462. doi: 10.1007/s10143-025-03625-8.
PubMed 40442402Huang C, Lei X, Feng X, Tong X, Wen Z, Lin J, Huang M, Peng C, Wang T, Chen W, Dai L, Jin X, Su S, Zhang X, Li X, Guo Z, Liu A, Duan C. Risk Factors for Incomplete Occlusion in Patients with Small Intracranial Aneurysms (<7 mm) after Flow-Diversion Treatment: A Multicenter Experience. Cerebrovasc Dis. 2025;54(6):865-872. doi: 10.1159/000544991. Epub 2025 Mar 3.
PubMed 40031881Huang J, Huang Y, Feng X, Huang C, Huang M, Wen Z, Xu A, Ge R, Yuan H, Shi H, Ma G, Li C, Lin J, Yi R, Hu Y, Jin Y, Liang S, Bi Y, Su S, Zhang X, Li X, Duan C. Predictive value of the systemic immune-inflammation index for periprocedural complications in flow diverter treatment for patients with intracranial aneurysms. Neurosurg Rev. 2024 Oct 22;47(1):809. doi: 10.1007/s10143-024-03053-0.
PubMed 39436476
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics
- ClinicalTrials.gov ID
- NCT06446778
- Acronym / sponsor ID
- LC2024ZD027
- Keywords
- intracranial aneurysms, flow-diverter device, Pipeline embolization device, in-stent stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Eighth Affiliated Hospital, Sun Yat-sen University, Zhongshan Hospital Of Traditional Chinese Medicine, First Affiliated Hospital of Jinan University, Beijing Tiantan Hospital, First Affiliated Hospital of Chongqing Medical University, Affiliated Hospital of Southwest Medical University, Guangdong 999 Brain Hospital, Shantou Central Hospital, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Harbin Medical University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 6 Jun 2024 (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.
This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization.
Detailed description
This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization. The primary outcomes were aneurysmal occlusion status, incidence of in-stent stenosis, and functional prognosis. The secondary outcomes were hemodynamic changes before and after stent implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saccular aneurysms | – | Device: Pipeline embolization device with or without shield techniquePatients with saccular aneurysms were enrolled. |
| Non-saccular aneurysms | – | Device: Pipeline embolization device with or without shield techniquePatients with non-saccular (i.e., fusiform, dissecting, blood blister-like) aneurysms were enrolled. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent Pipeline implantation for intracranial aneurysms
Key inclusion criteria (6 listed)
- Aged 22 to 75 years old, male or non-pregnant female;
- UIA was diagnosed by CTA, MRA, or DSA;
- The size of aneurysms is between 3 to 25mm;
- Understands the nature of the procedure and provision of written informed consent;
- Indications for FD implantation with or without adjunctive coiling;
Key exclusion criteria (9 listed)
- With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium;
- Pregnancy or lactation;
- Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);
- Parent vessel with a diameter <2.0 mm or ≥5.0 mm.;
- Unwilling to be followed up or likely to have poor treatment compliance;
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 |
|---|---|---|
| Pipeline embolization device with or without shield techniqueThe patients undenwent Pipeline embolization device implantation with or without shield technique due to market availability, choice and preferences of the surgeon. | Device | Non-saccular aneurysms, Saccular aneurysms |
Primary outcome
The occlusion rate of the aneurysm
Time frame: 1 years
The occlusion rate of the aneurysm at 6 months；O'Kelly Marotta classification: complete occlusion (D, entirely non-filling), near-complete occlusion (C, only entry remnant), and incomplete occlusion (A and B, subtotal and total filling).
2 secondary outcomes
in-stent stenosis
Time frame: 1 years
perioperative complications
Time frame: 1 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 42760406Ge R, Peng C, Chen W, Chen G, Li C, Guan P, Dai L, Wen Z, Huang C, Huang J, Lin J, Huang M, Yuan H, Yuan F, Wang Y, Bi Y, Su S, Zhang X, Li X, Liu A, Liang S, Duan C, Feng X. Pipeline Shield versus Pipeline Flex for unruptured intracranial aneurysms: a propensity-matched multicenter study. Neuroradiology. 2026 Sep 19. doi: 10.1007/s00234-026-04186-3. Online ahead of print.
- Derived from this study: PubMed 40442402Huang C, Zhu Y, Feng X, Tong X, Wen Z, Lin J, Huang M, Yuan H, Dai L, Chen W, Hu Y, Bi Y, Deng X, Xie Z, Shang G, Luo Y, Zhao Y, Peng C, Huang C, Su S, Zhang X, Li X, Guo Z, Liu A, Duan C. Stent match of pipeline embolization device: prediction of incomplete occlusion and in-stent stenosis by actual stent size after implantation. Neurosurg Rev. 2025 May 30;48(1):462. doi: 10.1007/s10143-025-03625-8.
- Derived from this study: PubMed 40031881Huang C, Lei X, Feng X, Tong X, Wen Z, Lin J, Huang M, Peng C, Wang T, Chen W, Dai L, Jin X, Su S, Zhang X, Li X, Guo Z, Liu A, Duan C. Risk Factors for Incomplete Occlusion in Patients with Small Intracranial Aneurysms (<7 mm) after Flow-Diversion Treatment: A Multicenter Experience. Cerebrovasc Dis. 2025;54(6):865-872. doi: 10.1159/000544991. Epub 2025 Mar 3.
- Derived from this study: PubMed 39436476Huang J, Huang Y, Feng X, Huang C, Huang M, Wen Z, Xu A, Ge R, Yuan H, Shi H, Ma G, Li C, Lin J, Yi R, Hu Y, Jin Y, Liang S, Bi Y, Su S, Zhang X, Li X, Duan C. Predictive value of the systemic immune-inflammation index for periprocedural complications in flow diverter treatment for patients with intracranial aneurysms. Neurosurg Rev. 2024 Oct 22;47(1):809. doi: 10.1007/s10143-024-03053-0.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Efficacy, Self
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Not yet recruitingPhase 2
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Aggressive Behavior in Fragile X Syndome
Recruiting
Dual Tasking Training to Enhance Self-Efficacy in Individuals With Parkinson's Disease
Parkinson´s Disease
Active, not recruiting
Online Written Imagery Rescripting for Shame and Negative Self-Cognitions in Malaysian Adults With Childhood Emotional Neglect
Shame, Childhood Emotional Neglect
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
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.
Chuanzhi Duan, MD study director
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy, Self and Hemodynamic Instability, run by Zhujiang Hospital 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 9 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: looking for participants now, as of the sponsor's last update on 18 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuanzhi Duan, MD (020-62782757, doctor_duanzj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occlusion rate of the aneurysm (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446778, which also lists 4 linked publications.
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 18 Nov 2024.