Cerebral Aneurysm
Conditions
Keywords
treatment trial, cerebral aneurysm, randomized, coils, endovascular, Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
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.
Interventions
DEVICEEndovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.
Sponsors
DePuy Synthes
Johnson & Johnson Medical Companies
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Recurrence of Lesion or Presence of Residual Aneurysm | 1 year | Major radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab |
| Hemorrhage During the Follow-up Period | Within 1 year following coiling | Post-treatment hemorrhage experienced during follow-up period. |
| Retreatment of the Same Lesion by Endovascular or Surgical Means | Within 1 year following coiling | Retreatment of the same lesion by endovascular or surgical means during the follow-up period |
| Initial Treatment Failure | Within 1 year following coiling | Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues. |
| Related Morbidity | Within 1 year following coiling | Morbidity that precludes follow up |
| Related Mortality | Within 1 year following coiling | Mortality that precludes follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Packing Density | within the first 3 days after coiling | Packing density with the number of coils implanted |
| Procedural Serious Adverse Events (SAEs) | Within 6 months following coiling | Procedural-related serious adverse events |
| Modified Rankin Score (mRS) Greater Than 2 | at 1 year follow-up | 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). |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment period: November 2013 to june 2017, from 12 centres in Canada and U.S.A.
Participants by arm
| Arm | Count |
|---|---|
| 15-caliber Platinum Coils Endovascular embolization coiling using 15-caliber platinum coils
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. | 104 |
| 10-caliber Coils Endovascular embolization coiling using standard 10-caliber platinum coils
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. | 106 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 7 |
| Overall Study | Lost to Follow-up | 3 | 4 |
Baseline characteristics
| Characteristic | 15-caliber Platinum Coils | 10-caliber Coils | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 11 | 57 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 82 Participants | 81 Participants | 163 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 104 | 7 / 106 |
| other Total, other adverse events | 8 / 104 | 20 / 106 |
| serious Total, serious adverse events | 7 / 104 | 18 / 106 |
Outcome results
Primary
Hemorrhage During the Follow-up Period
Post-treatment hemorrhage experienced during follow-up period.
Time frame: Within 1 year following coiling
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Hemorrhage During the Follow-up Period | 0 Participants |
| 10-caliber Coils | Hemorrhage During the Follow-up Period | 1 Participants |
Primary
Initial Treatment Failure
Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues.
Time frame: Within 1 year following coiling
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Initial Treatment Failure | 4 Participants |
| 10-caliber Coils | Initial Treatment Failure | 6 Participants |
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
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Major Recurrence of Lesion or Presence of Residual Aneurysm | 26 Participants |
| 10-caliber Coils | Major Recurrence of Lesion or Presence of Residual Aneurysm | 20 Participants |
Primary
Related Morbidity
Morbidity that precludes follow up
Time frame: Within 1 year following coiling
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Related Morbidity | 1 Participants |
| 10-caliber Coils | Related Morbidity | 0 Participants |
Primary
Related Mortality
Mortality that precludes follow up
Time frame: Within 1 year following coiling
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Related Mortality | 2 Participants |
| 10-caliber Coils | Related Mortality | 5 Participants |
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
Time frame: Within 1 year following coiling
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Retreatment of the Same Lesion by Endovascular or Surgical Means | 4 Participants |
| 10-caliber Coils | Retreatment of the Same Lesion by Endovascular or Surgical Means | 4 Participants |
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).
Time frame: at 1 year follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Modified Rankin Score (mRS) Greater Than 2 | 3 Participants |
| 10-caliber Coils | Modified Rankin Score (mRS) Greater Than 2 | 7 Participants |
Secondary
Packing Density
Packing density with the number of coils implanted
Time frame: within the first 3 days after coiling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 15-caliber Platinum Coils | Packing Density | 37.0 percentage of packing density | Standard Deviation 22.2 |
| 10-caliber Coils | Packing Density | 26.9 percentage of packing density | Standard Deviation 13 |
Secondary
Procedural Serious Adverse Events (SAEs)
Procedural-related serious adverse events
Time frame: Within 6 months following coiling
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 15-caliber Platinum Coils | Procedural Serious Adverse Events (SAEs) | 11 Participants |
| 10-caliber Coils | Procedural Serious Adverse Events (SAEs) | 15 Participants |