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NCT01407952 · ClinicalTrials.gov registry record · NA
Hydrogel Endovascular Aneurysm Treatment Trial
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 600
- Enrollment target
NCT01407952: Completed NA study, sponsored by Northwestern University.
NCT01407952 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 600 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01407952, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 600 participants
- Enrollment target
Study Summary
This research study is being done to test the effectiveness of a new generation FDA approved device for treating aneurysms compared to the current standard device for endovascular aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of minimally invasive surgery, which is performed on blood vessels. The technique involves the introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found near the groin. The catheter is then maneuvered through the body to the location of the aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter. This is repeated until enough coils fill the aneurysm, blocking the blood flow to the aneurysm. The body responds by forming blood clots around the coil(s), which helps block the flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study will compare the study device to the standard bare platinum coil to see which is better at preventing future rupturing or leaking. The study device is called the HydroCoil Embolization System and this study is a post-market clinical trial. About 600 subjects from multiple institutions will take part in this study.
Primary Outcome
Defined as any progression on the Raymond-Roy (RR) Aneurysm Occlusion Scale. The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.
Interventions
- DEVICE HydroCoil Embolic System
- DEVICE Control (bare platinum coils)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2012-04 |
| Est. Completion | 2018-03 |
| Phase | NA |
What the finished NCT01407952 record still lists
NCT01407952 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which HydroCoil Embolic System is the first listed.
NCT01407952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01407952 about?
NCT01407952 is a clinical study titled "Hydrogel Endovascular Aneurysm Treatment Trial". This research study is being done to test the effectiveness of a new generation FDA approved device for treating aneurysms compared to the current standard device for endovascular aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of minimally invasive surgery, which...
What is the current status of trial NCT01407952?
This trial is currently completed. It is a NA study. The enrollment target is 600 participants. The study started on 2012-04. Estimated completion is 2018-03.
What interventions are being tested in trial NCT01407952?
The interventions under investigation include: HydroCoil Embolic System (DEVICE), Control (bare platinum coils) (DEVICE).
Who is sponsoring clinical trial NCT01407952?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01407952's enrollment target sits among peer trials
600 162nd of 2000 higher than 1,827 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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