DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
DELTA
1 other identifier
interventional
210
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedStudy Start
First participant enrolled
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2018
CompletedResults Posted
Study results publicly available
January 22, 2020
CompletedJanuary 22, 2020
December 1, 2018
5.1 years
September 12, 2013
January 9, 2020
January 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (3)
Packing Density
within the first 3 days after coiling
Procedural Serious Adverse Events (SAEs)
Within 6 months following coiling
Modified Rankin Score (mRS) Greater Than 2
at 1 year follow-up
Study Arms (2)
15-caliber platinum coils
EXPERIMENTALEndovascular embolization coiling using 15-caliber platinum coils
10-caliber coils
ACTIVE COMPARATOREndovascular embolization coiling using standard 10-caliber platinum coils
Interventions
Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)lead
- DePuy Synthescollaborator
- Johnson & Johnson Medical Companiescollaborator
Study Sites (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
SUNY Upstate Medical University
Syracuse, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 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, T2N 2T9, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
McMaster University, Hamilton General Hospital
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1, Canada
Related Publications (1)
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.
PMID: 21571149BACKGROUND
MeSH Terms
Conditions
Limitations and Caveats
Trial was stopped before target number of patients were recruited due to funding being interrupted. Premature interruption of the trial does not allow a conclusion regarding the primary hypothesis.
Results Point of Contact
- Title
- Dr. Jean Raymond
- Organization
- Centre hospitalier de l'Université de Montréal Research Centre
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Raymond, MD
Centre hospitalier de l'Université de Montréal (CHUM)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 17, 2013
Study Start
November 13, 2013
Primary Completion
December 5, 2018
Study Completion
December 5, 2018
Last Updated
January 22, 2020
Results First Posted
January 22, 2020
Record last verified: 2018-12