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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
DePuy Synthes
Johnson & Johnson Medical Companies
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01943591
First received: September 12, 2013
Last updated: August 1, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Cerebral Aneurysm Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Major recurrence of lesion or presence of residual aneurysm [ Time Frame: 1 year ]
    Major radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab

  • Hemorrhage during the follow-up period [ Time Frame: Within 1 year following coiling ]
    Hemorrhage during the follow-up period

  • Retreatment of the same lesion by endovascular or surgical means [ Time Frame: Within 1 year following coiling ]
    Retreatment of the same lesion by endovascular or surgical means during the follow-up period

  • Occurrence or progression of a mass effect in relation to the treated aneurysm [ Time Frame: Within 1 year following coiling ]
    Occurrence or progression of a mass effect in relation to the treated aneurysm

  • Morbidity and mortality [ Time Frame: Within 1 year following coiling ]
    Morbidity and mortality that precludes follow up


Secondary Outcome Measures:
  • Major recurrence [ Time Frame: Within 1 year following coiling ]
    Major recurrence on follow up angiography

  • Morbidity and mortality [ Time Frame: Within 1 year following coiling ]
    Morbidity and mortality that precludes angiographic follow up

  • Use of adjunct devices [ Time Frame: within the first 30 days after coiling ]
    Use of adjunct devices

  • Packing density [ Time Frame: within the first 3 days after coiling ]
    Packing density with the number of coils implanted

  • Time of fluoroscopic exposure [ Time Frame: Within 1 year after coiling ]
    Time of fluoroscopic exposure

  • Procedural device-related serious adverse events [ Time Frame: Within 6 months following coiling ]
    Procedural device-related serious adverse events

  • Modified Rankin Score (mRS) [ Time Frame: at 1 year follow-up ]
    mRS at 1 year follow-up


Enrollment: 210
Study Start Date: November 13, 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943591

Locations
United States, Illinois
Presence Resurrection Medical Center
Chicago, Illinois, United States, 60631
University of Illinois at Chicago
Chicago, Illinois, United States
Presence Saint Hoseph Medical Center
Joliet, Illinois, United States, 60435
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States
United States, New York
Stony Brook University Medical Center (SUNY)
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
McMaster University, Hamilton General Hospital
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
DePuy Synthes
Johnson & Johnson Medical Companies
Investigators
Principal Investigator: Jean Raymond, MD Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01943591     History of Changes
Other Study ID Numbers: CE13.092
Study First Received: September 12, 2013
Last Updated: August 1, 2017

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
cerebral aneurysm
Aneurysm
Intracranial Aneurysm
Brain Diseases
treatment trial
randomized
coils
endovascular
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 22, 2017