An interventional study of Neqstent in Intracranial Aneurysm, sponsored by Cerus Endovascular, Inc.. Completed at 7 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Cerus Endovascular, Inc. · Not applicable, Interventional, and Treatment
Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy.
The purpose of the study is to document safety and performance of the Neqstent in adjunctive therapy in treatment for patients with intracranial aneurysms (IA).
Neqstent is designed as an adjunctive therapy for patients with unruptured and failed bifurcation aneurysm embolizations. Neqstent can be positioned at the neck of the aneurysm with or without existing coils and other embolization products. Embolization coils should be added to fill the dome of the aneurysm after placement of Neqstent.
427 studies on the registry are indexed under Intracranial Aneurysm; 114 are open to participants now.
This study's enrollment of 38 is below the median of 115 across 206 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Cerus Endovascular, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
The Proportion of Subjects With Death of Any Non-accidental Cause or Any Major Disabling Stroke After Treatment or Major Disabling Stroke or Death Due to Neurological Cause.
Time frame: From day 31 to 6 months after treatment
The Proportion of Subjects With Complete Occlusion
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
Time frame: 6 months
| Milestone | Intervention/Neqstent |
|---|---|
| Started | 38 |
| Completed | 32 |
| Not completed | 6 |
| Participants | Intervention/Neqstent |
|---|---|
| The Proportion of Subjects With Death of Any Non-accidental Cause or Any Major Disabling Stroke After Treatment or Major Disabling Stroke or Death Due to Neurological Cause. | 2 |
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
| Participants | Intervention/Neqstent |
|---|---|
| The Proportion of Subjects With Complete Occlusion | 26 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention/Neqstent | 1/37 (2.7%) | 15/37 (40.5%) | 19/37 (51.4%) |
| Event | Intervention/Neqstent |
|---|---|
| StrokeNervous system disorders | 7/37 |
| Non-index Aneurysm TreatmentNervous system disorders | 2/37 |
| Aneurysm ReccurenceNervous system disorders | 1/37 |
| HeadacheNervous system disorders | 1/37 |
| DepressionPsychiatric disorders | 1/37 |
| Shoulder InjuryInjury, poisoning and procedural complications | 1/37 |
| Distal Embolic PhenomenonNervous system disorders | 1/37 |
| Hemorrhagic StrokeNervous system disorders | 1/37 |
| Device MovementInvestigations | 1/37 |
| SeizureNervous system disorders | 1/37 |
| Event | Intervention/Neqstent |
|---|---|
| Access Site - HematomaVascular disorders | 4/37 |
| HeadacheNervous system disorders | 4/37 |
| Headache and NosebleedNervous system disorders | 1/37 |
| StrokeNervous system disorders | 1/37 |
| Disorientation with trouble speakingGeneral disorders | 1/37 |
| TinnitusNervous system disorders | 1/37 |
| Dental SurgerySurgical and medical procedures | 1/37 |
| Radiation induced epilationSkin and subcutaneous tissue disorders | 1/37 |
| VomitingGeneral disorders | 1/37 |
| Femoral Artery DissectionInjury, poisoning and procedural complications | 1/37 |
All patients; 38 patients were listed in the Participant Flow, and all 38 patients were included in the population description.
| Age, Categorical(Participants) | Intervention/Neqstent |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 12 |
| Sex: Female, Male(Participants) | Intervention/Neqstent |
|---|---|
| Female | 28 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Intervention/Neqstent |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 36 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Intervention/Neqstent |
|---|---|
| Canada | 5 |
| Austria | 2 |
| Denmark | 17 |
| Switzerland | 1 |
| Germany | 13 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Cerus Endovascular, Inc.