DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
- Conditions
- Cerebral Aneurysm
- Interventions
- Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
- Registration Number
- NCT01943591
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10-caliber coils Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils Endovascular embolization coiling using standard 10-caliber platinum coils 15-caliber platinum coils Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils Endovascular embolization coiling using 15-caliber platinum coils
- Primary Outcome Measures
Name Time Method Related Mortality Within 1 year following coiling Mortality that precludes follow up
Major Recurrence of Lesion or Presence of Residual Aneurysm 1 year Major radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab
Retreatment of the Same Lesion by Endovascular or Surgical Means Within 1 year following coiling Retreatment of the same lesion by endovascular or surgical means during the follow-up period
Hemorrhage During the Follow-up Period Within 1 year following coiling Post-treatment hemorrhage experienced during follow-up period.
Initial Treatment Failure Within 1 year following coiling Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues.
Related Morbidity Within 1 year following coiling Morbidity that precludes follow up
- Secondary Outcome Measures
Name Time Method Packing Density within the first 3 days after coiling Packing density with the number of coils implanted
Modified Rankin Score (mRS) Greater Than 2 at 1 year follow-up 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).
Procedural Serious Adverse Events (SAEs) Within 6 months following coiling Procedural-related serious adverse events
Trial Locations
- Locations (15)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Stony Brook University Medical Center (SUNY)
🇺🇸Stony Brook, New York, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
McMaster University, Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada