Trials / Terminated
TerminatedNCT04391803
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Medtronic Neurovascular Clinical Affairs · Industry
- Sex
- All
- Age
- 22 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
Detailed description
The ELEVATE study is a prospective, multi-center, single-arm trial of the Pipeline™ Shield Device for the treatment of adults with acutely ruptured intracranial aneurysms. The primary objective of the ELEVATE study is to assess the safety and effectiveness of treatment with the Pipeline™ Shield Device of acutely ruptured intracranial aneurysms that are not amenable for clipping and coiling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pipeline™ Flex Embolization Device with Shield Technology™ | The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular treatment of adults with intracranial acutely ruptured aneurysms not amenable to clipping and coiling. |
Timeline
- Start date
- 2022-05-06
- Primary completion
- 2025-10-20
- Completion
- 2025-10-20
- First posted
- 2020-05-18
- Last updated
- 2026-01-27
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04391803. Inclusion in this directory is not an endorsement.