Trial Outcomes & Findings for DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial (NCT NCT01943591)
NCT ID: NCT01943591
Last Updated: 2020-01-22
Results Overview
Major radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
210 participants
Primary outcome timeframe
1 year
Results posted on
2020-01-22
Participant Flow
Recruitment period: November 2013 to june 2017, from 12 centres in Canada and U.S.A.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
106
|
|
Overall Study
COMPLETED
|
99
|
95
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Death
|
2
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10 • n=104 Participants
|
57 years
STANDARD_DEVIATION 11 • n=106 Participants
|
57 years
STANDARD_DEVIATION 10 • n=210 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=104 Participants
|
81 Participants
n=106 Participants
|
163 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=104 Participants
|
25 Participants
n=106 Participants
|
47 Participants
n=210 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 yearMajor radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Major Recurrence of Lesion or Presence of Residual Aneurysm
|
26 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Within 1 year following coilingPost-treatment hemorrhage experienced during follow-up period.
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Hemorrhage During the Follow-up Period
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 1 year following coilingRetreatment of the same lesion by endovascular or surgical means during the follow-up period
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Retreatment of the Same Lesion by Endovascular or Surgical Means
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Within 1 year following coilingInability to treat aneurysm, either because access to aneurysm is difficult or technical issues.
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Initial Treatment Failure
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Within 1 year following coilingMorbidity that precludes follow up
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Related Morbidity
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 1 year following coilingMortality that precludes follow up
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Related Mortality
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: within the first 3 days after coilingPacking density with the number of coils implanted
Outcome measures
| Measure |
15-caliber Platinum Coils
n=100 Participants
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.
|
10-caliber Coils
n=99 Participants
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.
|
|---|---|---|
|
Packing Density
|
37.0 percentage of packing density
Standard Deviation 22.2
|
26.9 percentage of packing density
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Within 6 months following coilingProcedural-related serious adverse events
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Procedural Serious Adverse Events (SAEs)
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: at 1 year follow-upModified 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).
Outcome measures
| Measure |
15-caliber Platinum Coils
n=104 Participants
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.
|
10-caliber Coils
n=106 Participants
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.
|
|---|---|---|
|
Modified Rankin Score (mRS) Greater Than 2
|
3 Participants
|
7 Participants
|
Adverse Events
15-caliber Platinum Coils
Serious events: 7 serious events
Other events: 8 other events
Deaths: 2 deaths
10-caliber Coils
Serious events: 18 serious events
Other events: 20 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
15-caliber Platinum Coils
n=104 participants at risk
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.
|
10-caliber Coils
n=106 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Aneurysm rupture during procedure causing Mortality
|
0.96%
1/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
1.9%
2/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
Stroke, periprocedure causing mortality
|
0.00%
0/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
1.9%
2/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
Stroke, related to SAH at presentation causing mortality
|
0.00%
0/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
0.94%
1/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
Subarachnoid hemorrhage during follow-up causing mortality
|
0.96%
1/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
0.00%
0/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
General disorders
Event unrelated to aneurysm or its treatment causing mortality
|
0.00%
0/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
1.9%
2/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Surgical and medical procedures
Aneurysm rupture during procedure causing morbidity
|
2.9%
3/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
3.8%
4/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
Stroke, causing morbidity
|
1.9%
2/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
5.7%
6/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
SAH during follow-up, causing morbidity
|
0.00%
0/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
0.94%
1/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
Other adverse events
| Measure |
15-caliber Platinum Coils
n=104 participants at risk
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.
|
10-caliber Coils
n=106 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Hemorrhage (aneurysm rupture during procedure)
|
3.8%
4/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
5.7%
6/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
Stroke
|
1.9%
2/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
10.4%
11/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
Subarachnoid Hemorrhage during follow-up
|
0.96%
1/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
0.94%
1/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
|
Vascular disorders
Transient ischemic attack (TIA)
|
0.96%
1/104 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
1.9%
2/106 • Adverse Events are reported for a time period of within 1 year post aneurysm treatment.
|
Additional Information
Dr. Jean Raymond
Centre hospitalier de l'Université de Montréal Research Centre
Phone: 514-890-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER