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Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)
NA trial testing Pipeline™ Vantage Embolization Device with Shield Technology™ in Intracranial Aneurysm in 14 participants. Terminated before completion.
| Lead sponsor | Medtronic Neurovascular Clinical Affairs |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 2 April 2020 |
| Primary completion | 22 July 2021 |
| Estimated completion | 18 September 2023 |
| Sites | 3 locations across United States |
Medtronic Neurovascular Clinical Affairs — full company profile →
Adults 22 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.
Incidence of major stroke in the territory supplied by the treated artery or neurological death.
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 1 |
Incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1-year post-procedure.
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 6 |
Incidence of successful device implantation at the target site
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 9 |
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
| Group | Value | 95% CI |
|---|---|---|
| Pipeline™ Vantage Embolization Device With Shield Technology™ | 6 |
Incidence of target aneurysm recurrence at 1 year post-procedure
| Group | Value | 95% CI |
|---|---|---|
| Pipeline™ Vantage Embolization Device With Shield Technology™ | 0 |
Incidence of major stroke in the territory supplied by the treated artery or neurological death
| Group | Value | 95% CI |
|---|---|---|
| Pipeline™ Vantage Embolization Device With Shield Technology™ | 0 |
Incidence of major stroke in the territory supplied by the treated artery or neurological death
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 1 |
Incidence of delayed intraparenchymal hemorrhage \>30 days post-procedure through 1-year post-procedure
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 0 |
Incidence of subjects with disabling strokes that have a mRS decline to a score of 3 or more (mRS ≥ 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event
| Group | Value | 95% CI |
|---|---|---|
| Pipeline™ Vantage Embolization Device With Shield Technology™ | 1 |
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
| Group | Value | 95% CI |
|---|---|---|
| Pipeline™ Vantage Embolization Device With Shield Technology™ | 0 |
Incidence of target aneurysm recurrence 3-years post-procedure
| Group | Value | 95% CI |
|---|---|---|
| Pipeline™ Vantage Embolization Device With Shield Technology™ | 0 |
Time frame: Adverse event data were collected for each subject from the time of consent through 3 years post-procedure.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Study Group |
|---|---|---|
| Cerebral Hematoma | Nervous system disorders | — |
| Cerebrovascular Accident | Nervous system disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Cerebral Endovascular Aneurysm Repair | Surgical and medical procedures | — |
| Reaction | System | Study Group |
|---|---|---|
| Urinary Tract Infection | Infections and infestations | — |
| Vasospasm | Vascular disorders | — |
| Normocytic Anemia | Blood and lymphatic system disorders | — |
| Bradycardia | Cardiac disorders | — |
| Hemorrhoids | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Asthenia | General disorders | — |
| Chest Pain | General disorders | — |
| Vascular Stent Stenosis | General disorders | — |
| Kidney Infection | Infections and infestations | — |
| Vascular Access Site Discharge | Injury, poisoning and procedural complications | — |
| Vascular Access Site Hematoma | Injury, poisoning and procedural complications | — |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | — |
| Paraesthesia | Nervous system disorders | — |
| Menorrhagia | Reproductive system and breast disorders | — |
| Vaginal Hemorrhage | Reproductive system and breast disorders | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — |
| Cerebral Artery Stenosis | Nervous system disorders | — |
| Hematoma | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Cerebral Hematoma, Cerebrovascular Accident, Encephalopathy, Cerebral Endovascular Aneurysm Repair.
Data from ClinicalTrials.gov NCT03873714 adverse events section.
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing