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NCT01943591 · ClinicalTrials.gov registry record · NA
DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
A NA study, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- Completed
- Registry status
- NA
- Development phase
- 210
- Enrollment target
NCT01943591 is a NA study that has completed, run by Centre hospitalier de l'Université de Montréal (CHUM). The registered enrollment target is 210 participants.
The verdict
NCT01943591, a NA study, has completed, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- COMPLETED
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
Study Summary
Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of intracranial aneurysms. Unfortunately, endovascular treatment of aneurysms with coils has been associated with incomplete occlusion at initial treatment (remnant) or at follow-up (recurrence). This in some studies has been as high as 20%. While many such aneurysm remnants or recurrences exhibit benign behavior, many require retreatment to prevent future hemorrhage. A recent randomized controlled trial of aneurysm coiling revealed that aneurysms between 2 and 9.9 mm diameter were more likely to have an improved angiographic and composite clinical outcome when treated with hydrogel-coated coils, an improvement inferred to result from higher packing density afforded by hydrogel expansion(1). The use of hydrogel coils is associated with technical difficulties related to expansion and limited time for deployment. The investigators theorize that similar results could be achieved by using more voluminous bare platinum coils, leading to improved packing density compared to smaller caliber coils, and thus result in lower incidence of remnants or residuals. The relationship between packing densities and composite clinical endpoints having never been shown in a robust fashion, the investigators therefore propose a randomized clinical trial opposing coiling with soft 15-caliber coils to 10-caliber bare platinum coils in aneurysms varying in size from 3 to 9.9 mm. To test the hypothesis that 15-caliber coiling systems are superior to standard 10-caliber coils in achieving better composite outcomes, the investigators propose the DELTA trial: Does Embolization with Larger coils lead to better Treatment of Aneurysms trial, a randomized controlled blinded trial with 2 subgroups of 282 patients each, 564 total: Subgroup 1: Coiled with a maximum proportion of 15-caliber coils as conditions allow Subgroup 2: Coiled with 10-caliber coils.
Interventions
- DEVICE Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2013-11-13 |
| Est. Completion | 2018-12-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01943591
The ClinicalTrials.gov registry entry for NCT01943591 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centre hospitalier de l'Université de Montréal (CHUM), which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils is the first listed.
NCT01943591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01943591 about?
NCT01943591 is a clinical study titled "DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial". Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of intracranial aneurysms. Unfortunately, endovascular treatment of aneurysms with coils has been associated with incomplete occlusion at initial treatment (remnant) or at follow-up (recurrence). This in some s...
What is the current status of trial NCT01943591?
This trial is currently completed. It is a NA study. The enrollment target is 210 participants. The study started on 2013-11-13. Estimated completion is 2018-12-05.
What interventions are being tested in trial NCT01943591?
The interventions under investigation include: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils (DEVICE).
Who is sponsoring clinical trial NCT01943591?
This trial is sponsored by Centre hospitalier de l'Université de Montréal (CHUM), which has 10 total clinical trials registered on ClinicalTrials.gov.
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