Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01943591
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2013-09-12
Brief Title:
DELTA Trial Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
DELTA Trial Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELTA
Brief 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 99 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 expansion1 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 99 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
A recent randomized controlled trial of aneurysm coiling revealed that aneurysms between 2 and 99 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 expansion1 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 99 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None