Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
CompletedNAResults postedLast updated 27 December 2019
What this trial tests
NA trial testing Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device in Intracranial Aneurysm in 197 participants. Completed in 13 December 2018.
Adults 22 to 80, any sex, with Intracranial Aneurysm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post ProcedurePrimary· Up to 12 Months Post Procedure
The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination
Group
Value
95% CI
PREMIER
2.17
The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-ProcedurePrimary· Up to 12 Months Post Procedure
The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusio
Group
Value
95% CI
PREMIER
76.71
The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural ComplicationsSecondary· Up to 30 days, Post Procedure
Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.
Group
Value
95% CI
PREMIER
0
The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-ProcedureSecondary· > 30 days, Post Procedure
For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.
Group
Value
95% CI
PREMIER
1
The Number of Participants With Successfully Deployed Investigational DeviceSecondary· Index Procedure
The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.
Group
Value
95% CI
PREMIER
140
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected from the point of consent through year 3.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06588543 — Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping
· recruiting
NCT05831202 — SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
· Phase 3
· active not recruiting
NCT06416657 — General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Usin
· NA
· recruiting
Other Medtronic Neurovascular Clinical Affairs trials
Trials by the same sponsor.
NCT04391803 — EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization De
· NA
· terminated
NCT05005962 — Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
· completed
NCT04416659 — Flow Arrest Safety and Technical Success With Balloon Guide Catheters
· completed
NCT04402632 — Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
· NA
· completed
NCT03873714 — Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)
· NA
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medtronic Neurovascular Clinical Affairs
Last refreshed: 27 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02186561.