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Neuroform Atlas Stent System Study
NA trial testing Next Generation Neuroform Stent System in Intracranial Aneurysm in 298 participants. Completed in 30 September 2022.
| Lead sponsor | Stryker Neurovascular |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 298 |
| Start date | 18 June 2015 |
| Primary completion | 13 December 2021 |
| Estimated completion | 30 September 2022 |
| Sites | 25 locations across United States |
Stryker Neurovascular — full company profile →
Adults 18 to 80, any sex, with Intracranial Aneurysm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Any major ipsilateral stroke or neurological death
| Group | Value | 95% CI |
|---|---|---|
| Neuroform Atlas Stent System (Anterior) | 8 | |
| Neuroform Atlas Stent System (Posterior) | 5 |
Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 12 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.
| Group | Value | 95% CI |
|---|---|---|
| Neuroform Atlas Stent System (Anterior) | 135 | |
| Neuroform Atlas Stent System (Posterior) | 81 |
The percent of subjects experiencing one or more serious adverse events (SAEs) through 12 months including * New or worsening major ipsilateral stroke as measured by the National Institute of Health Stroke Scale (NIHSS) * Device-related SAEs * Subarachnoid hemorrhage (SAH) * Aneurysm rupture
| Group | Value | 95% CI |
|---|---|---|
| Neuroform Atlas Stent System (Anterior) | 20 | |
| Neuroform Atlas Stent System (Posterior) | 19 |
Time frame: 12 months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Next Generation Neuroform … |
|---|---|---|
| Intracerebral aneurysm operation | Surgical and medical procedures | — |
| Ischaemic stroke | Nervous system disorders | — |
| Transient ischaemic attack | Nervous system disorders | — |
| Subarachnoid haemorrhage | Nervous system disorders | — |
| Chest pain | General disorders | — |
| Convulsion or seizure | Nervous system disorders | — |
| Application site hematoma | General disorders | — |
| Migraine or status migrainosis | Nervous system disorders | — |
| Thrombosis in device | Vascular disorders | — |
| Blurred vision | Eye disorders | — |
| Gastrointestinal hemmorhage | Gastrointestinal disorders | — |
| Subdural hematoma | Injury, poisoning and procedural complications | — |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | — |
| Headache | Nervous system disorders | — |
| Syncope | Nervous system disorders | — |
| Ruptured cerebral aneurysm | Nervous system disorders | — |
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Retroperitoneal hemorrhage | Vascular disorders | — |
| Cerebral artery embolism | Nervous system disorders | — |
| Cerebral infarction | Nervous system disorders | — |
| Embolic stroke | Nervous system disorders | — |
| Myelodysplastic Syndrome | Blood and lymphatic system disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Cardiomyopathy | Cardiac disorders | — |
| Cardiac failure congestive | Cardiac disorders | — |
| Reaction | System | Next Generation Neuroform … |
|---|---|---|
| Headache | Nervous system disorders | — |
| Infection | Infections and infestations | — |
| Cerebral vasoconstriction | Nervous system disorders | — |
| Application site injury | General disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Dizziness | Nervous system disorders | — |
| Nausea or vomiting | Gastrointestinal disorders | — |
| Blurred vision, diplopia, vision impairment or reduced acuity | Eye disorders | — |
| Other musculoskeletal pain | Musculoskeletal and connective tissue disorders | — |
| Hypoaesthesia | Nervous system disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Abdominal pain or discomfort | Gastrointestinal disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Increased tendency to bruise | Blood and lymphatic system disorders | — |
| Arrhythmia, tachycardia, afib or bradycardia | Cardiac disorders | — |
| Any pain | General disorders | — |
| Respiratory tract infection | Infections and infestations | — |
| Fall | Musculoskeletal and connective tissue disorders | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — |
| Photophobia | Eye disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Hypotension | Vascular disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — |
| Convulsion | Nervous system disorders | — |
| Hypertension | Vascular disorders | — |
| Ear pain | Ear and labyrinth disorders | — |
| Vitreous floaters | Eye disorders | — |
| Chest pain | General disorders | — |
| Asthenia | General disorders | — |
| Pneumonia | Infections and infestations | — |
| Vertebral artery dissection | Nervous system disorders | — |
| Transient ischemic attack | Nervous system disorders | — |
| Hemiparesis | Nervous system disorders | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Contusion | Vascular disorders | — |
| Thrombosis in device | Vascular disorders | — |
Most-reported serious reactions: Intracerebral aneurysm operation, Ischaemic stroke, Transient ischaemic attack, Subarachnoid haemorrhage, Chest pain, Convulsion or seizure, Application site hematoma, Migraine or status migrainosis.
Data from ClinicalTrials.gov NCT02340585 adverse events section.
The primary objective of this study is to demonstrate effectiveness and safety of the Neuroform Atlas Stent System for use with bare metal embolic coils.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing