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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
| Johnson & Johnson Medical Companies | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15-caliber platinum coils | Experimental | Endovascular embolization coiling using 15-caliber platinum coils |
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| 10-caliber coils | Active Comparator | Endovascular embolization coiling using standard 10-caliber platinum coils |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils | Device | Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hemorrhage During the Follow-up Period | Post-treatment hemorrhage experienced during follow-up period. | Within 1 year following coiling |
| 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 |
| Initial Treatment Failure | Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues. | Within 1 year following coiling |
| Related Morbidity | Morbidity that precludes follow up | Within 1 year following coiling |
| Related Mortality | Mortality that precludes follow up | Within 1 year following coiling |
| Measure | Description | Time Frame |
|---|---|---|
| Packing Density | Packing density with the number of coils implanted | within the first 3 days after coiling |
| Procedural Serious Adverse Events (SAEs) | Procedural-related serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Raymond, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | United States | |||
| University of Massachusetts Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21571149 | Background | 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. |
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Recruitment period: November 2013 to june 2017, from 12 centres in Canada and U.S.A.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 10-caliber Coils |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2015 |
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| Within 6 months following coiling |
| 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 |
| 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 | T2N 2T9 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| McMaster University, Hamilton General Hospital | Hamilton | Ontario | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 0C1 | Canada |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 1 year |
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| Primary | Hemorrhage During the Follow-up Period | Post-treatment hemorrhage experienced during follow-up period. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Within 1 year following coiling |
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| Primary | Initial Treatment Failure | Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues. | Posted | Count of Participants | Participants | Within 1 year following coiling |
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| Primary | Related Morbidity | Morbidity that precludes follow up | Posted | Count of Participants | Participants | Within 1 year following coiling |
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| Secondary | Packing Density | Packing density with the number of coils implanted | Posted | Mean | Standard Deviation | percentage of packing density | within the first 3 days after coiling |
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| Secondary | Procedural Serious Adverse Events (SAEs) | Procedural-related serious adverse events | Posted | Count of Participants | Participants | Within 6 months following coiling |
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| 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). | Posted | Count of Participants | Participants | at 1 year follow-up |
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| Primary | Related Mortality | Mortality that precludes follow up | Posted | Count of Participants | Participants | Within 1 year following coiling |
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Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 104 | 7 | 104 | 8 | 104 |
| EG001 | 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. | 7 | 106 | 18 | 106 | 20 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm rupture during procedure causing Mortality | Surgical and medical procedures | Systematic Assessment |
| ||
| Stroke, periprocedure causing mortality | Vascular disorders | Systematic Assessment |
| ||
| Stroke, related to SAH at presentation causing mortality | Vascular disorders | Systematic Assessment |
| ||
| Subarachnoid hemorrhage during follow-up causing mortality | Vascular disorders | Systematic Assessment |
| ||
| Event unrelated to aneurysm or its treatment causing mortality | General disorders | Non-systematic Assessment |
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| Aneurysm rupture during procedure causing morbidity | Surgical and medical procedures | Systematic Assessment |
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| Stroke, causing morbidity | Vascular disorders | Systematic Assessment |
| ||
| SAH during follow-up, causing morbidity | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage (aneurysm rupture during procedure) | Vascular disorders | Systematic Assessment |
| ||
| Stroke | Vascular disorders | Systematic Assessment |
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| Subarachnoid Hemorrhage during follow-up | Vascular disorders | Systematic Assessment |
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| Transient ischemic attack (TIA) | Vascular disorders | Systematic Assessment |
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Trial was stopped before target number of patients were recruited due to funding being interrupted.
Premature interruption of the trial does not allow a conclusion regarding the primary hypothesis.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than 12 months after the conclusion of the study at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Raymond | Centre hospitalier de l'Université de Montréal Research Centre | 514-890-8000 | 27235 | jraymond.nri@gmail.com |
| Dec 17, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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