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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Aneurysm
• Intervention / Treatment: Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Center
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University, Hamilton General Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Université de Montréal
• United States
  • Illinois
    • Chicago, Illinois, United States
      • University of Illinois at Chicago
  • Massachusetts
    • Worcester, Massachusetts, United States
      • University of Massachusetts Medical School
  • New York
    • Stony Brook, New York, United States
      • Stony Brook University Medical Center (SUNY)
    • Syracuse, New York, United States
      • SUNY Upstate Medical University
  • South Carolina
    • Charleston, South Carolina, United States
      • Medical University of South Carolina
  • Tennessee
    • Knoxville, Tennessee, United States
      • University of Tennessee Medical Center
  • Virginia
    • Charlottesville, Virginia, United States
      • University of Virginia Health System
  • West Virginia
    • Morgantown, West Virginia, United States
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: DePuy Synthes; Johnson & Johnson Medical Companies
• Investigators: Principal Investigator: Jean Raymond, MD, Centre hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 13, 2013
• Primary Completion (Actual): December 5, 2018
• Study Completion (Actual): December 5, 2018

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Nervous System Diseases; Central Nervous System Diseases; endovascular; Aneurysm; randomized; treatment trial; Brain Diseases; cerebral aneurysm; coils; Intracranial Aneurysm; Intracranial Arterial Diseases; Cerebrovascular Disorders
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CE13.092

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No