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

Cerebral Aneurysm Clinical Trial

— DELTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943591
• Other study ID #: CE13.092
• Status: Completed
• Phase: N/A
• Start date: November 13, 2013
• Est. completion date: December 5, 2018

Study information

• Verified date: December 2018
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 5, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	McMaster University, Hamilton General Hospital	Hamilton	Ontario
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Stony Brook University Medical Center (SUNY)	Stony Brook	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	DePuy Synthes, Johnson & Johnson Medical Companies

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Recurrence of Lesion or Presence of Residual Aneurysm	Major radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab	1 year
Primary	Hemorrhage During the Follow-up Period	Post-treatment hemorrhage experienced during follow-up period.	Within 1 year following coiling
Primary	Retreatment of the Same Lesion by Endovascular or Surgical Means	Retreatment of the same lesion by endovascular or surgical means during the follow-up period	Within 1 year following coiling
Primary	Initial Treatment Failure	Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues.	Within 1 year following coiling
Primary	Related Morbidity	Morbidity that precludes follow up	Within 1 year following coiling
Primary	Related Mortality	Mortality that precludes follow up	Within 1 year following coiling
Secondary	Packing Density	Packing density with the number of coils implanted	within the first 3 days after coiling
Secondary	Procedural Serious Adverse Events (SAEs)	Procedural-related serious adverse events	Within 6 months following coiling
Secondary	Modified Rankin Score (mRS) Greater Than 2	Modified Rankin Score (mRS) that is greater than 2 at 1 year follow-up (or at last follow-up, if applicable). Minimum = 0 (no symptoms), maximum = 6 (Deceased).	at 1 year follow-up