Intracranial AneurysmPED-ISSNCT06715930

Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients With Intracranial Aneurysm

An observational study of Intracranial Aneurysm, run by Beijing Tiantan Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Intracranial Aneurysm
What is being tested?: Interventional treatment
Type of treatment: Surgery or procedure
How many people: 1,500 participants
Where: 1 siteChina
Study dates: 1 Apr 2016to 1 Oct 2025
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients diagnosis of "unruptured intracranial aneurysm" treated with PEDs.

Who may be able to join

Patients aged18 to 75 years;
IAs patients treated with PEDs;
patients whose parent artery did not have significant atherosclerotic stenosis;
patients who had at least one digital subtraction angiography (DSA) follow-up.

Who cannot join

Patients missing critical clinical baseline;
patients with inadequate DSA image quality for reliable assessment;
patients with comorbid cerebrovascular conditions, including arteriovenous fistulas and arteriovenous malformations;
patients without any follow-up information.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients With Intracranial Aneurysm: a Multicenter, Retrospective Model Development and Validation Study

Intracranial aneurysms (IAs) are the primary cause of non-traumatic subarachnoid hemorrhage with high morbidity and mortality. Flow diverters, such as pipeline embolization devices (PEDs), are among the most effective methods for treating IAs in recent years due to the maturity of interventional devices and minimally invasive techniques. Unlike conventional stents, PEDs modify the hemodynamics within the parent artery and aneurysm sac, allowing blood flow from the aneurysm sac, thus facilitating endothelialization of the aneurysm neck. As a result, aneurysms are completely removed from circulation with time. However, about 5.1%-38.5% of IA patients develop in-stent stenosis (ISS) even after successful PED implantation. ISS increases the risk of retreatment and ischemic complications, thereby affecting the long-term prognosis of IA patients. Therefore, preoperative determination of the patient's suitability for PED implantation can enhance patient-centered decision-making and improve the long-term prognosis of IA patients.

Although previous studies have evaluated the correlation between certain individual variables and ISS, there are few comprehensive models predicting ISS after PED treatment. Nomograms have been widely used for prediction of tumor survival and cardiovascular events. Nomograms incorporate multiple risk factors for predicting the patient's potential prognosis based on their individual risks. This study aimed to identify the predictors for ISS after PED treatment and to create and verify a nomogram for assessing individual risk.

Conditions: Intracranial Aneurysm
Being tested: Interventional treatment
Keywords: Intracranial aneurysm, In-stent stenosis, Pipeline embolization device, Nomogram
Medical subject headings: Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interventional treatmentProcedure or surgery
The procedure was performed via the traditional transfemoral arterial approach, under general anesthesia and complete heparin anticoagulation. PEDs were introduced using Marksman or Phenom-27 microcatheters (Medtronic, Irvine, USA), while coils were introduced via Echelon-10 microcatheters (Medtronic, Dublin, Ireland). An appropriate working projection was used to generate three-dimensional rotational angiography. Un-subtracted images were used to verify whether PED was completely deployed and attached to the parent artery. Wall apposition was enhanced using balloon angioplasty if post-deployment imaging indicated inadequate apposition. Overlapping devices were used when a single PED was not enough to cover the aneurysm neck and reconstruct blood flow. Neurointerventionalists with more than 15 years of experience conducted all endovascular procedures. The same dual-antiplatelet therapy was used for 6 months post-procedure, followed by aspirin monotherapy for a minimum of 12 months.

Study groups in NCT06715930
Study group	Role	What they receive
ISS group		Patients presenting with in-stent stenosis (ISS) at imaging follow-up. ISS was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the pipeline embolization device. Receives: Procedure: Interventional treatment
Non-ISS group		Patients withou in-stent stenosis (ISS) at imaging follow-up. ISS was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the pipeline embolization device. Receives: Procedure: Interventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

In-stent stenosis
In-stent stenosis was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the PED.
Measured: 6 months, 1 year, and 3 years after treatment.

Secondary outcomes (2)

Complete occlusion at the last angiographic follow-up
At follow-up, the patient's aneurysm was completely occluded, with an OKM score of grade D.
O'Kelly-Marotta grading scale was used to assess aneurysm occlusion status following PED treatment. Grade D indicated complete occlusion, while grades A, B, and C represented incomplete occlusion
Measured: 6 months, 1 year, and 3 years after treatment
Procedure-related complications
Procedure-related complications were divided into hemorrhagic, ischemic, and compression symptoms. Hemorrhagic complications were defined as subarachnoid hemorrhage or distal intraparenchymal hemorrhage after PED implantation. Ischemic complications included in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area. Compression symptoms included neurological symptoms or brain stem symptoms associated with aneurysm compression.
Measured: 6 months, 1 year, and 3 years after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20161 Oct 2025

First posted4 Dec 2024
Study start1 Apr 2016
Primary completion1 Oct 2023
Study completion1 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 1,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06715930
Sponsor's protocol ID: PED-ISS
Acronym: PED-ISS
Status last verified: Nov 2024
First submitted: 28 Nov 2024
Last updated: 4 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Turhon M, Kang H, Liu J, Zhang Y, Zhang Y, Huang J, Wang K, Li M, Liu J, Zhang H, Li T, Song D, Zhao Y, Luo B, Maimaiti A, Aisha M, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Guan S. In-Stent Stenosis After Pipeline Embolization Device in Intracranial Aneurysms: Incidence, Predictors, and Clinical Outcomes. Neurosurgery. 2022 Dec 1;91(6):943-951. doi: 10.1227/neu.0000000000002142. Epub 2022 Sep 21.
PubMed 36129281
John S, Bain MD, Hui FK, Hussain MS, Masaryk TJ, Rasmussen PA, Toth G. Long-term Follow-up of In-stent Stenosis After Pipeline Flow Diversion Treatment of Intracranial Aneurysms. Neurosurgery. 2016 Jun;78(6):862-7. doi: 10.1227/NEU.0000000000001146.
PubMed 26600281
Wang T, Richard SA, Jiao H, Li J, Lin S, Zhang C, Wang C, Xie X, You C. Institutional experience of in-stent stenosis after pipeline flow diverter implantation: A retrospective analysis of 6 isolated cases out of 118 patients. Medicine (Baltimore). 2021 Mar 19;100(11):e25149. doi: 10.1097/MD.0000000000025149.
PubMed 33725998
Dong L, Wang C, Chen X, Li M, Li T, Liu H, Zhao Y, Duan R, Jin W, Zhang Y, Wang Y, Lv M. Predicting Persistent Aneurysm Filling After Pipeline Embolization Device Treatment in Patients with Intracranial Aneurysm: Development and External Validation of a Nomogram Model. Transl Stroke Res. 2025 Apr;16(2):392-402. doi: 10.1007/s12975-023-01222-9. Epub 2023 Dec 8.
PubMed 38066403
Kadirvel R, Ding YH, Dai D, Rezek I, Lewis DA, Kallmes DF. Cellular mechanisms of aneurysm occlusion after treatment with a flow diverter. Radiology. 2014 Feb;270(2):394-9. doi: 10.1148/radiol.13130796. Epub 2013 Oct 28.
PubMed 24086073
Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
PubMed 33447904
Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013 Jun;267(3):858-68. doi: 10.1148/radiol.13120099. Epub 2013 Feb 15.
PubMed 23418004
Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, Istvan IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.
PubMed 35292570
Thompson BG, Brown RD Jr, Amin-Hanjani S, Broderick JP, Cockroft KM, Connolly ES Jr, Duckwiler GR, Harris CC, Howard VJ, Johnston SC, Meyers PM, Molyneux A, Ogilvy CS, Ringer AJ, Torner J; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention; American Heart Association; American Stroke Association. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Aug;46(8):2368-400. doi: 10.1161/STR.0000000000000070. Epub 2015 Jun 18.
PubMed 26089327
Liu Q, Li K, He H, Miao Z, Cui H, Wu J, Ding S, Wen Z, Chen J, Lu X, Li J, Zheng L, Wang S. The markers and risk stratification model of intracranial aneurysm instability in a large Chinese cohort. Sci Bull (Beijing). 2023 Jun 15;68(11):1162-1175. doi: 10.1016/j.scib.2023.05.001. Epub 2023 May 10.
PubMed 37210332

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intracranial Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients With Intracranial Aneurysm: a Multicenter, Retrospective Model Development and Validation Study
ClinicalTrials.gov ID: NCT06715930
Acronym / sponsor ID: PED-ISS / PED-ISS
Conditions: Intracranial Aneurysm
Keywords: Intracranial aneurysm, In-stent stenosis, Pipeline embolization device, Nomogram
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 1,500 participants (estimated)
Lead sponsor: Beijing Tiantan HospitalUniversity, hospital or other
Collaborators: Beijing Chao Yang Hospital, Peking University International Hospital
Study start: 1 Apr 2016 (actual)
Primary completion: 1 Oct 2023 (actual)
Study completion: 1 Oct 2025 (estimated)
First posted: 4 Dec 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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
ISS group	–	Procedure: Interventional treatmentPatients presenting with in-stent stenosis (ISS) at imaging follow-up. ISS was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the pipeline embolization device.
Non-ISS group	–	Procedure: Interventional treatmentPatients withou in-stent stenosis (ISS) at imaging follow-up. ISS was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the pipeline embolization device.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients diagnosis of "unruptured intracranial aneurysm" treated with PEDs.

Key inclusion criteria (4 listed)

Patients aged18 to 75 years;
IAs patients treated with PEDs;
patients whose parent artery did not have significant atherosclerotic stenosis;
patients who had at least one digital subtraction angiography (DSA) follow-up.

Key exclusion criteria (4 listed)

Patients missing critical clinical baseline;
patients with inadequate DSA image quality for reliable assessment;
patients with comorbid cerebrovascular conditions, including arteriovenous fistulas and arteriovenous malformations;
patients without any follow-up information.

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
Interventional treatmentThe procedure was performed via the traditional transfemoral arterial approach, under general anesthesia and complete heparin anticoagulation. PEDs were introduced using Marksman or Phenom-27 microcatheters (Medtronic, Irvine, USA), while coils were introduced via Echelon-10 microcatheters (Medtronic, Dublin, Ireland). An appropriate working projection was used to generate three-dimensional rotational angiography. Un-subtracted images were used to verify whether PED was completely deployed and attached to the parent artery. Wall apposition was enhanced using balloon angioplasty if post-deployment imaging indicated inadequate apposition. Overlapping devices were used when a single PED was not enough to cover the aneurysm neck and reconstruct blood flow. Neurointerventionalists with more than 15 years of experience conducted all endovascular procedures. The same dual-antiplatelet therapy was used for 6 months post-procedure, followed by aspirin monotherapy for a minimum of 12 months.	Procedure or surgery	ISS group, Non-ISS group

Primary outcome

In-stent stenosis
Time frame: 6 months, 1 year, and 3 years after treatment.
In-stent stenosis was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the PED.

2 secondary outcomes

Complete occlusion at the last angiographic follow-up
Time frame: 6 months, 1 year, and 3 years after treatment
Procedure-related complications
Time frame: 6 months, 1 year, and 3 years after treatment

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 4 Dec 2024.
Results publication: PubMed 36129281Turhon M, Kang H, Liu J, Zhang Y, Zhang Y, Huang J, Wang K, Li M, Liu J, Zhang H, Li T, Song D, Zhao Y, Luo B, Maimaiti A, Aisha M, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Guan S. In-Stent Stenosis After Pipeline Embolization Device in Intracranial Aneurysms: Incidence, Predictors, and Clinical Outcomes. Neurosurgery. 2022 Dec 1;91(6):943-951. doi: 10.1227/neu.0000000000002142. Epub 2022 Sep 21.
Results publication: PubMed 26600281John S, Bain MD, Hui FK, Hussain MS, Masaryk TJ, Rasmussen PA, Toth G. Long-term Follow-up of In-stent Stenosis After Pipeline Flow Diversion Treatment of Intracranial Aneurysms. Neurosurgery. 2016 Jun;78(6):862-7. doi: 10.1227/NEU.0000000000001146.
Results publication: PubMed 33725998Wang T, Richard SA, Jiao H, Li J, Lin S, Zhang C, Wang C, Xie X, You C. Institutional experience of in-stent stenosis after pipeline flow diverter implantation: A retrospective analysis of 6 isolated cases out of 118 patients. Medicine (Baltimore). 2021 Mar 19;100(11):e25149. doi: 10.1097/MD.0000000000025149.
Results publication: PubMed 38066403Dong L, Wang C, Chen X, Li M, Li T, Liu H, Zhao Y, Duan R, Jin W, Zhang Y, Wang Y, Lv M. Predicting Persistent Aneurysm Filling After Pipeline Embolization Device Treatment in Patients with Intracranial Aneurysm: Development and External Validation of a Nomogram Model. Transl Stroke Res. 2025 Apr;16(2):392-402. doi: 10.1007/s12975-023-01222-9. Epub 2023 Dec 8.
Results publication: PubMed 24086073Kadirvel R, Ding YH, Dai D, Rezek I, Lewis DA, Kallmes DF. Cellular mechanisms of aneurysm occlusion after treatment with a flow diverter. Radiology. 2014 Feb;270(2):394-9. doi: 10.1148/radiol.13130796. Epub 2013 Oct 28.
Results publication: PubMed 33447904Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
Results publication: PubMed 23418004Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013 Jun;267(3):858-68. doi: 10.1148/radiol.13120099. Epub 2013 Feb 15.
Results publication: PubMed 35292570Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, Istvan IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.
Results publication: PubMed 26089327Thompson BG, Brown RD Jr, Amin-Hanjani S, Broderick JP, Cockroft KM, Connolly ES Jr, Duckwiler GR, Harris CC, Howard VJ, Johnston SC, Meyers PM, Molyneux A, Ogilvy CS, Ringer AJ, Torner J; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention; American Heart Association; American Stroke Association. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Aug;46(8):2368-400. doi: 10.1161/STR.0000000000000070. Epub 2015 Jun 18.
Results publication: PubMed 37210332Liu Q, Li K, He H, Miao Z, Cui H, Wu J, Ding S, Wen Z, Chen J, Lu X, Li J, Zheng L, Wang S. The markers and risk stratification model of intracranial aneurysm instability in a large Chinese cohort. Sci Bull (Beijing). 2023 Jun 15;68(11):1162-1175. doi: 10.1016/j.scib.2023.05.001. Epub 2023 May 10.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 Intracranial Aneurysm, run by Beijing Tiantan 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent stenosis (time frame: 6 months, 1 year, and 3 years after treatment.). 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 NCT06715930, which also lists 10 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 4 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.