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

NCT ID: NCT01943591

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-13
• Study Completion Date: 2018-12-05

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.

Conditions

Cerebral Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

15-caliber platinum coils

Endovascular embolization coiling using 15-caliber platinum coils

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.

10-caliber coils

Endovascular embolization coiling using standard 10-caliber platinum coils

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Medical Companies

INDUSTRY

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Raymond, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Stony Brook University Medical Center (SUNY)

Stony Brook, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

University of Virginia Health System

Charlottesville, Virginia, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

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

Ottawa Hospital

Ottawa, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 21571149 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CE13.092

Identifier Type: -

Identifier Source: org_study_id