Cerebral AneurysmDELTANCT01943591
DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
A study testing Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils in people with Cerebral Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 15 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 13 Nov 2013to 5 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States8 sites
Medical University of South Carolina
Charleston, South Carolina
University of Virginia Health System
Charlottesville, Virginia
University of Illinois at Chicago
Chicago, Illinois
University of Tennessee Medical Center
Knoxville, Tennessee
West Virginia University Hospital
Morgantown, West Virginia
Stony Brook University Medical Center (SUNY)
Stony Brook, New York
SUNY Upstate Medical University
Syracuse, New York
University of Massachusetts Medical School
Worcester, Massachusetts
Canada7 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
McMaster University, Hamilton General Hospital
Hamilton, Ontario
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
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.
Read more
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
- Being tested
- Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
- 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
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coilsDevice
Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.
| Study group | Role | What they receive |
|---|---|---|
| 15-caliber platinum coils | Experimental | Endovascular embolization coiling using 15-caliber platinum coils Receives: Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils |
| 10-caliber coils | Active comparator | Endovascular embolization coiling using standard 10-caliber platinum coils Receives: Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Hemorrhage During the Follow-up Period
Post-treatment hemorrhage experienced during follow-up period.
Measured: 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
Measured: Within 1 year following coiling
Initial Treatment Failure
Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues.
Measured: Within 1 year following coiling
Related Morbidity
Morbidity that precludes follow up
Measured: Within 1 year following coiling
Related Mortality
Mortality that precludes follow up
Measured: Within 1 year following coiling
Secondary outcomes (3)
Packing Density
Packing density with the number of coils implanted
Measured: within the first 3 days after coiling
Procedural Serious Adverse Events (SAEs)
Procedural-related serious adverse events
Measured: 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).
Measured: at 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study start13 Nov 2013
- Primary completion5 Dec 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes, Johnson & Johnson Medical Companies
- Responsible party
- Sponsor
- Investigators
- Jean Raymond, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943591
- Sponsor's protocol ID
- CE13.092
- Acronym
- DELTA
- Status last verified
- Dec 2018
- First submitted
- 12 Sep 2013
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21571149
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
- ClinicalTrials.gov ID
- NCT01943591
- Acronym / sponsor ID
- DELTA / CE13.092
- Conditions
- Cerebral Aneurysm
- Keywords
- treatment trial, cerebral aneurysm, randomized, coils, endovascular, Aneurysm, Intracranial Aneurysm, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- DePuy Synthes, Johnson & Johnson Medical Companies
- Study start
- 13 Nov 2013
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15-caliber platinum coils | Experimental | Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coilsEndovascular embolization coiling using 15-caliber platinum coils |
| 10-caliber coils | Active comparator | Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coilsEndovascular embolization coiling using standard 10-caliber platinum coils |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coilsEmbolization using 15-caliber platinum coils or standard 10-caliber platinum coils. | Device | 10-caliber coils, 15-caliber platinum coils |
Primary outcome
Major Recurrence of Lesion or Presence of Residual Aneurysm
Time frame: 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
Time frame: Within 1 year following coiling
Post-treatment hemorrhage experienced during follow-up period.
Retreatment of the Same Lesion by Endovascular or Surgical Means
Time frame: Within 1 year following coiling
Retreatment of the same lesion by endovascular or surgical means during the follow-up period
Initial Treatment Failure
Time frame: Within 1 year following coiling
Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues.
Related Morbidity
Time frame: Within 1 year following coiling
Morbidity that precludes follow up
Related Mortality
Time frame: Within 1 year following coiling
Mortality that precludes follow up
3 secondary outcomes
Packing Density
Time frame: within the first 3 days after coiling
Procedural Serious Adverse Events (SAEs)
Time frame: Within 6 months following coiling
Modified Rankin Score (mRS) Greater Than 2
Time frame: at 1 year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21571149White 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Raymond, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils in people with Cerebral Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Recurrence of Lesion or Presence of Residual Aneurysm (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01943591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.