Recruiting

Observational Study

Sponsor:

Montefiore Medical Center

Code:

NCT06174727

Conditions

Intracranial Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.

Conditions

Intracranial Aneurysm

Study ID

NCT06174727

Start date

Oct 1, 2023

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Consecutive adult patients (18 years of age or older)
  • Underwent endovascular treatment with one of the following devices:

a. Endoluminal Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (Stryker Neurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X; MicroVention) viii. p64 Flow Modulation Device (phenox GmbH) ix. Endovascular clip system (eCLIPs) (eCLIPsTM, eVasc Neurovascular, Vancouver, BC, Canada)

b. Intrasaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii. Luna/Artisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA)
  • Complete medical records and follow-up data available

Exclusion Criteria:

  • Incomplete procedural or follow-up records
  • Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)
  • Aneurysms treated with investigational devices not listed within Inclusion Criteria

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Technical Success [ Time Frame: Periprocedurally, up to 24 hours ]
  • Procedural Complications following placement [ Time Frame: From the time of the procedure up to 1 month post treatment ]
  • Clinical Outcomes at Discharge [ Time Frame: Upon study discharge, up to 4 weeks ]
  • Clinical Outcomes at last available Follow-up [ Time Frame: Up to 24 months post procedure ]
  • Immediate Angiographic Outcomes at Discharge - O'Kelly-Marotta (OKM) grading scale [ Time Frame: Upon study discharge, up to 4 weeks ]
  • Immediate Angiographic Outcomes at Discharge - Modified Raymond-Roy Classification (mRRC) [ Time Frame: Upon study discharge, up to 4 weeks ]
  • Immediate Angiographic Outcomes at Discharge - WEB Occlusion Scale (WOS) [ Time Frame: Upon study discharge, up to 4 weeks ]
  • Angiographic Outcomes at last available Follow-up - O'Kelly-Marotta (OKM) grading scale [ Time Frame: Up to 24 months post procedure ]
  • Angiographic Outcomes at last available Follow-up - Modified Raymond-Roy Classification (mRRC) [ Time Frame: Up to 24 months post procedure ]
  • Angiographic Outcomes at last available Follow-up - WEB Occlusion Scale (WOS) [ Time Frame: Up to 24 months post procedure ]

Central Contacts and Locations

Central contacts

Muhammed Amir Essibayi, MD

347-908-1889Muhammedamir.essibayi@einsteinmed.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Robert M Starke, MD, MS

305-355-1101RStarke@med.miami.edu

Principal Investigator:

Robert M Starke, MD, MS

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Timo Krings, MD, PhD, MSc

781-744-3330Timo.Krings@lahey.org

Principal Investigator:

Timo Krings, MD, PhD, MSc

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Amy Peterson, PhD

231-935-6746apeterson4@mhc.net

Allina Health

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Collin M Torok, MD

612-863-0376collin.torok@allina.com

Marie Meyer, MA

marie.meyer@allina.com

Principal Investigator:

Collin M Torok, MD

Robert Wood Johnson University

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Gaurav Gupta, MD

732-235-6333guptaga@rwjms.rutgers.edu

Principal Investigator:

Gaurav Gupta, MD

Montefiore Medical Center Department of Neurosurgery

Recruiting

The Bronx, New York, United States, 10467

Contacts

Muhammed Amir Essibayi, MD

347-908-1889Muhammedamir.essibayi@einsteinmed.edu

David Altschul, MD

(718) 920-7498daltschu@montefiore.org

Principal Investigator:

David Altschul, MD

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Vitor Mendes Pereira, MD

416-864-5131PereiraReferrals@unityhealth.to

Eileen Liu, MSc

eileen.liu@unityhealth.to

Principal Investigator:

Vitor Mendes Pereira, MD

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Pascal Mosimann, MD, PD

416-603 5800pascal.mosimann@uhn.ca

Principal Investigator:

Pascal Mosimann, MD, PD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Endovascular
  • Registry
  • Flow Diverter Stents
  • Endosaccular Flow Disruptors
  • Flow Diversion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-07-10.