Clinical trial NCT01943591: DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
Official title: DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Aneurysm
Keywords: 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
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
name: Johnson & Johnson Medical Companies
First posted: 2013-09-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major Recurrence of Lesion or Presence of Residual Aneurysm
timeFrame: 1 year
measure: Hemorrhage During the Follow-up Period
timeFrame: Within 1 year following coiling
measure: Retreatment of the Same Lesion by Endovascular or Surgical Means
timeFrame: Within 1 year following coiling
measure: Initial Treatment Failure
timeFrame: Within 1 year following coiling
measure: Related Morbidity
timeFrame: Within 1 year following coiling
measure: Related Mortality
timeFrame: Within 1 year following coiling
Secondary outcomes:
measure: Packing Density
timeFrame: within the first 3 days after coiling
measure: Procedural Serious Adverse Events (SAEs)
timeFrame: Within 6 months following coiling
measure: Modified Rankin Score (mRS) Greater Than 2
timeFrame: at 1 year follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center (SUNY)
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University, Hamilton General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Jean Raymond, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: White PM, Lewis SC, Gholkar A, Sellar RJ, Nahser H, Cognard C, Forrester L, Wardlaw JM; HELPS trial collaborators. Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial. Lancet. 2011 May 14;377(9778):1655-62. doi: 10.1016/S0140-6736(11)60408-X.