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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01943591
First received: September 12, 2013
Last updated: March 13, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Hemorrhage during the follow-up period

  • Retreatment of the same lesion by endovascular or surgical means [ Time Frame: Within 1 year following coiling ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Occurrence or progression of a mass effect in relation to the treated aneurysm

  • Morbidity and mortality [ Time Frame: Within 1 year following coiling ] [ Designated as safety issue: Yes ]
    Morbidity and mortality that precludes follow up


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

  • Morbidity and mortality [ Time Frame: Within 1 year following coiling ] [ Designated as safety issue: Yes ]
    Morbidity and mortality that precludes angiographic follow up

  • Use of adjunct devices [ Time Frame: within the first 30 days after coiling ] [ Designated as safety issue: No ]
    Use of adjunct devices

  • Packing density [ Time Frame: within the first 3 days after coiling ] [ Designated as safety issue: No ]
    Packing density with the number of coils implanted

  • Time of fluoroscopic exposure [ Time Frame: Within 1 year after coiling ] [ Designated as safety issue: No ]
    Time of fluoroscopic exposure

  • Procedural device-related serious adverse events [ Time Frame: Within 6 months following coiling ] [ Designated as safety issue: Yes ]
    Procedural device-related serious adverse events

  • Modified Rankin Score (mRS) [ Time Frame: at 1 year follow-up ] [ Designated as safety issue: Yes ]
    mRS at 1 year follow-up


Estimated Enrollment: 564
Study Start Date: October 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: Endovascular coiling with 15-caliber platinum coils
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: Endovascular coiling with 10-caliber coils
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Jean Raymond, MD 514-890-8000 ext 27235 jraymond.nri@gmail.com
Contact: Suzanne Nolet 514-890-8000 ext 26359 Suzanne.Nolet@crchum.qc.ca

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Not yet recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Suzanne Nolet    514-890-8000 ext 26359    Suzanne.Nolet@crchum.qc.ca   
Principal Investigator: Jean Raymond, MD         
Centre hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2L4M1
Contact: Suzanne Nolet    514 890-8000 ext 26359    Suzanne.Nolet@crchum.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Jean Raymond, MD Centre Hospitalier de l'Université de Montréal
  More Information

Publications:
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: March 13, 2014
Health Authority: Canada: Ethics Review Committee

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 July 20, 2014