title: Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial.
abstract: BACKGROUND
  Endovascular coil embolization of cerebral aneurysms is an effective treatment for the prevention of aneurysm rebleeding after subarachnoid hemorrhage. It is also often used in unruptured aneurysms, but it is associated with aneurysm remnants and recurrences in up to 20%-33% of patients. We hypothesized that better aneurysm occlusion rates can be achieved with coils of larger caliber.
  
  
  METHODS
  The Does Embolization with Larger coils lead to better Treatment of Aneurysms (DELTA) trial is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial. To test the hypothesis that 15-caliber coiling systems are superior to 10-caliber coils, 564 patients with aneurysms measuring 4-12 mm will be randomized 1:1 to embolization with either 10-caliber coils exclusively (control group) or the highest safely achievable proportion of 15-caliber coils (intervention group). The primary efficacy endpoint of the trial is the occurrence of a major recurrence or a residual aneurysm at one year. A pilot phase of 165 patients will be conducted to verify feasibility of the coiling strategy, compliance to treatment allocation, safety of a 15-caliber platinum coil embolization strategy, recruitment rates, and the capacity to improve packing density.
  
  
  CONCLUSIONS
  The DELTA trial will test the hypothesis that the use of coils of larger caliber can improve angiographic results of endovascular coiling.
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: Jimmy
authors.initials: J
authors.lastname: Ghostine
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: Naim
authors.initials: N
authors.lastname: Khoury
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: Francis
authors.initials: F
authors.lastname: Cloutier
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: Marc
authors.initials: M
authors.lastname: Kotowski
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Gentric
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: André L
authors.initials: AL
authors.lastname: Batista
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: Alain
authors.initials: A
authors.lastname: Weill
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Roy
authors.affiliation: University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division of Neurosurgery, Canada.
authors.forename: Tim E
authors.initials: TE
authors.lastname: Darsaut
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, Canada jean.raymond@umontreal.ca.
authors.forename: Jean
authors.initials: J
authors.lastname: Raymond
mesh_terms: D000368:Aged; D017542:Aneurysm, Ruptured / Q000628:therapy; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D000072226:Computed Tomography Angiography; D057510:Endovascular Procedures / Q000009:adverse effects / Q000379:methods*; D023381:Endpoint Determination; D004867:Equipment Design; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D010984:Platinum; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome
chemical_list: D010984:Platinum
keywords: Cerebral aneurysm; controlled trial; endovascular coil embolization; packing density; randomized