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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Major Recurrence of Lesion or Presence of Residual Aneurysm

Secondary Outcome

 Packing Density

Condition

Cerebral Aneurysm

Intervention

Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils

Study Arms / Comparison Groups

 15-caliber platinum coils
Description:  Endovascular embolization coiling using 15-caliber platinum coils

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

210

Start Date

November 13, 2013

Completion Date

December 5, 2018

Primary Completion Date

December 5, 2018

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean Raymond, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01943591

Organization ID

CE13.092


Responsible Party

Sponsor

Study Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

 DePuy Synthes

Study Sponsor

Jean Raymond, MD, Principal Investigator, Centre hospitalier de l'Université de Montréal (CHUM)


Verification Date

December 2018