Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 12, 2013
March 13, 2014
October 2013
March 2019   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01943591 on ClinicalTrials.gov Archive Site
  • 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
  • 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: Yes ]
    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
Not Provided
Not Provided
 
DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Aneurysm
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.
  • Experimental: Endovascular coiling with 15-caliber platinum coils
    15-caliber platinum coils
    Intervention: Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
  • Active Comparator: Endovascular coiling with 10-caliber coils
    Standard 10-caliber platinum coils
    Intervention: Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
564
September 2019
March 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Canada
 
NCT01943591
CE13.092
Yes
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Not Provided
Principal Investigator: Jean Raymond, MD Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP