DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial

Study Overview
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Brief Summary
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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.

Official Title
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DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial

Conditions
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Cerebral Aneurysm

Intervention / Treatment
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* Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one ruptured or unruptured aneurysms with a dimension ≥ 10 mm (longest axis) for ruptured lesions, patients should be in World Federation of Neurosurgical Societies (WFNS) grade < IV. The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable) Patient is 18 or older Life expectancy is more than 2 years (able to complete follow-up) Exclusion Criteria: Patients with planned treatment of an associated cerebral arteriovenous malformations When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15-caliber platinum coils<br>Endovascular embolization coiling using 15-caliber platinum coils | Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils<br>* Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.<br>|
| Active Comparator: 10-caliber coils<br>Endovascular embolization coiling using standard 10-caliber platinum coils | Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils<br>* Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Recurrence of Lesion or Presence of Residual Aneurysm | Major radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab | 1 year | 
| Hemorrhage During the Follow-up Period | Post-treatment hemorrhage experienced during follow-up period. | Within 1 year following coiling | 
| Retreatment of the Same Lesion by Endovascular or Surgical Means | Retreatment of the same lesion by endovascular or surgical means during the follow-up period | Within 1 year following coiling | 
| Initial Treatment Failure | Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues. | Within 1 year following coiling | 
| Related Morbidity | Morbidity that precludes follow up | Within 1 year following coiling | 
| Related Mortality | Mortality that precludes follow up | Within 1 year following coiling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Packing Density | Packing density with the number of coils implanted | within the first 3 days after coiling | 
| Procedural Serious Adverse Events (SAEs) | Procedural-related serious adverse events | Within 6 months following coiling | 
| Modified Rankin Score (mRS) Greater Than 2 | Modified Rankin Score (mRS) that is greater than 2 at 1 year follow-up (or at last follow-up, if applicable). Minimum = 0 (no symptoms), maximum = 6 (Deceased). | at 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment trial, cerebral aneurysm, randomized, coils, endovascular, Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases