DELTA


 

Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of intracranial aneurysms.  Unfortunately, endovascular treatment has been associated with incomplete occlusion at initial treatment (remnant) or at follow-up (recurrence).  This in some studies has been as high as 33%.   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. We 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. Aneurysms varying in size from 4 to 12 mm are most prevalent, and it is in these smaller aneurysms that both smaller caliber or larger caliber coils can be used. The relationship between packing densities and clinical endpoints having never been shown in a robust fashion in these small aneurysms, we 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 4 to 12 mm.

 

To test the hypothesis that 15-caliber coiling systems are superior to standard 10-caliber coils in achieving better composite outcomes, we 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 platinum coils

                      (including  Deltamaxx) as conditions allow

§  Subgroup 2: Coiled with 10-caliber platinum coils.

 

The pivotal trial will be preceded by a pilot phase of approximately 165 patients designed to verify the feasibility of the coiling strategy, compliance to treatment group allocation, the safety of an 15-caliber platinum coil embolization strategy, recruitment rates, and the capacity to improve packing density (to 28%) with a standardized effect size (E/S) of 0.6, with a power of 95% and a two-sided alpha error of 0.05 (assuming the packing density of the control group will be approximately 25%).

 

DELTA is registered at clinicaltrials.gov: NCT01943591.  

SelectionFile type iconFile nameDescriptionSizeRevisionTimeUser
Ċ
View Download
  458k v. 1 Jan 26, 2016, 7:59 AM Guylaine Gevry
Ċ
View Download
  751k v. 1 Jan 26, 2016, 8:00 AM Guylaine Gevry
Ċ
View Download
  99k v. 1 Jan 26, 2016, 8:01 AM Guylaine Gevry
Ċ
View Download
  1114k v. 1 Jun 17, 2014, 1:19 PM Guylaine Gevry
Comments