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Coil Assisted Flow Diversion Safety and Performance Study
NA trial testing Neqstent in Intracranial Aneurysm in 38 participants. Completed in 1 November 2023.
| Lead sponsor | Cerus Endovascular, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 21 January 2020 |
| Primary completion | 17 June 2022 |
| Estimated completion | 1 November 2023 |
| Sites | 7 locations across Denmark, Austria, Germany, Canada, Switzerland |
Cerus Endovascular, Inc. — 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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention/Neqstent | 2 |
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
| Group | Value | 95% CI |
|---|---|---|
| Intervention/Neqstent | 26 |
Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention/Neqstent |
|---|---|---|
| Stroke | Nervous system disorders | — |
| Non-index Aneurysm Treatment | Nervous system disorders | — |
| Aneurysm Reccurence | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Depression | Psychiatric disorders | — |
| Shoulder Injury | Injury, poisoning and procedural complications | — |
| Distal Embolic Phenomenon | Nervous system disorders | — |
| Hemorrhagic Stroke | Nervous system disorders | — |
| Device Movement | Investigations | — |
| Seizure | Nervous system disorders | — |
| Target Aneurysm Rupture | Injury, poisoning and procedural complications | — |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Rotator Cuff Injury | Musculoskeletal and connective tissue disorders | — |
| Vasculitis | Vascular disorders | — |
| Access Site - Hematoma | Vascular disorders | — |
| Suicide Attempt | Psychiatric disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Reaction | System | Intervention/Neqstent |
|---|---|---|
| Access Site - Hematoma | Vascular disorders | — |
| Headache | Nervous system disorders | — |
| Headache and Nosebleed | Nervous system disorders | — |
| Stroke | Nervous system disorders | — |
| Disorientation with trouble speaking | General disorders | — |
| Tinnitus | Nervous system disorders | — |
| Dental Surgery | Surgical and medical procedures | — |
| Radiation induced epilation | Skin and subcutaneous tissue disorders | — |
| Vomiting | General disorders | — |
| Femoral Artery Dissection | Injury, poisoning and procedural complications | — |
| Chest Pain | Cardiac disorders | — |
| Numbness | Nervous system disorders | — |
| Vasovagal Episode | Cardiac disorders | — |
| Dysaesthesia | Nervous system disorders | — |
| Fractured Fibula | Injury, poisoning and procedural complications | — |
| Pulmonary Abcess | Respiratory, thoracic and mediastinal disorders | — |
| Bleeding Event (Non-neurological) | General disorders | — |
| Dizziness/Fall | General disorders | — |
Most-reported serious reactions: Stroke, Non-index Aneurysm Treatment, Aneurysm Reccurence, Headache, Depression, Shoulder Injury, Distal Embolic Phenomenon, Hemorrhagic Stroke.
Data from ClinicalTrials.gov NCT04187573 adverse events section.
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).
1 peer-reviewed publication reference this trial (live from Europe PMC):
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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/NCT04187573.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing