Trials / Active Not Recruiting
Active Not RecruitingNCT04572230
International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach
IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 405 (actual)
- Sponsor
- Stryker Neurovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.
Detailed description
IMPACT is an international, prospective, observational, multicenter, non-randomized, post market study designed to provide ongoing safety and performance evaluation on implantable devices used for the treatment of intracranial aneurysms with an endovascular approach. Data collection will also include details on adjunctive and ancillary devices used. In addition, to gaining safety and performance data, this study will provide clinical evidence that may assist physicians in selecting an appropriate device(s) while describing treatment options used to treat patients with intracranial aneurysms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endovascular treatment of intracranial aneurysms using a flow-diverting stent | The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow. |
Timeline
- Start date
- 2020-12-21
- Primary completion
- 2024-10-24
- Completion
- 2025-08-01
- First posted
- 2020-10-01
- Last updated
- 2025-08-07
Locations
32 sites across 7 countries: Austria, Finland, France, Germany, Italy, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT04572230. Inclusion in this directory is not an endorsement.