Subarachnoid HemorrhageCOVERAGENCT05171465
Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE
An observational study of Subarachnoid Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
Rationale: Intrasaccular neck occlusion devices have been used for unruptured aneurysm without safety concerns and good occlusion rates. In the setting of a subarachnoid hemorrhage, they could improve the rate of complete occlusion without safety concerns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Neqstent or Contour
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Mar 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: COVERAGE study is a multicentric and international study developed in high volume centers with previous experienced using intrasaccular neck occlusion devices. Patients that met all eligibility criteria are considered for enrolment. We include patients with SAH due to a ruptured intracranial saccular aneurysm and mild to moderate clinical symptoms (World Federation Neurological Surgeons ≤ III).
Who may be able to join
- Acute subarachnoid hemorrhage due to an intracranial ruptured aneurysm. Diagnosis must be done with acute CT or MRI.
- Intracranial saccular aneurysm with neck diameter 2-11mm and neck-dome height ≥2 mm.
- Clinical severity measured by World Federation Neurological Surgeons scale score ≤ III.
- Age ≥18 years.
- Previous modified Rankin scale ≤2.
- Informed consent obtained from the patient or acceptable patient surrogate.
Who cannot join
- Hemodynamically unstable patients with requirement of advanced vital support.
- Patients with limited life expectancy (<6 months) due to terminal disease.
- Previous antiplatelet or anticoagulation treatment.
- Participation in any other clinical trial with a drug or device which could influence the outcome.
- Patients with neurological or psychiatric disease that could undermine future evaluations.
- Lack of availability for 12 months tracing.
Trial locations and contacts
No sites are listed yet.
About this study
Rationale: Intrasaccular neck occlusion devices have been used for unruptured aneurysm without safety concerns and good occlusion rates. In the setting of a subarachnoid hemorrhage, they could improve the rate of complete occlusion without safety concerns.
Aim: To explore the safety and efficacy of intrasaccular neck occlusion devices in patients with acute subarachnoid hemorrhage caused by a ruptured saccular aneurysm by a one arm prospective registry.
Study outcome: The primary outcomes is the rate of complete occlusion (Raymond-Roy I) and rebleeding at one year follow-up. The primary safety outcome is rate of rebleeding during the admission.
- Being tested
- Neqstent or Contour
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neqstent or ContourDevice
All patients included will be treated the same: after catheterizing the affected vessel and microcatheterizing the aneurysm with a microcatheter of 0.021'' or 0.027'', the intrasaccular device (Neqstent® or Contour®) will be positioned. Depending of the operator preference, the use of an intrasaccular device could be associated with coiling (mandatory in the case of Neqstent®). Treatment must be performed without previous double antiplatelet treatment (allowing antiplatelet after aneurysm exclusion). Before the treatment all patients should undergo a flat panel CT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy achieving the lack of rebleeding
Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding
Measured: 12 months
Efficacy achieving the complete occlusion
Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at 12 months follow-up evaluated by an image central core lab.
Measured: 12 months
Secondary outcomes (9)
Analysis of the primary outcomes in different subgroups
Analysis of the primary outcomes in different subgroups: anterior versus vertebrobasilar circulation, narrow versus wide (≥4mm) neck, aneurysm size (<10mm versus ≥10mm).
Measured: 12 months
Efficacy achieving the complete occlusion at end of treatment
Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at end of treatment.
Measured: 1 day
Rate of patients who underwent the study treatment.
Rate of patients who were included in the study and finally underwent the study treatment.
Measured: 1 days
Rate of retreatment
Rate of retreatment needed during the follow-up.
Measured: 12 months
Rate of mortality during admission or follow-up.
Rate of mortality during admission or follow-up.
Measured: 12 months
Functional outcome
Functional outcome at 12 months measured by modified Rankin scale.
Measured: 12 months
Rate of vascular thrombosis or acute stroke.
Rate of vascular thrombosis or acute stroke during follow-up.
Measured: 12 months
Rate of early rebleeding.
Rate of early rebleeding during the admission.
Measured: 30 days.
Rate of complications associated with the procedure.
Rate of complications associated with the procedure.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startMar 2022 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171465
- Sponsor's protocol ID
- PR(AG)564/2021
- Acronym
- COVERAGE
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Under reasoned request for metaanalysis or pooled data analysis
Publications
Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5.
PubMed 16139655Molyneux AJ, Kerr RS, Birks J, Ramzi N, Yarnold J, Sneade M, Rischmiller J; ISAT Collaborators. Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol. 2009 May;8(5):427-33. doi: 10.1016/S1474-4422(09)70080-8. Epub 2009 Mar 28.
PubMed 19329361Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Vinuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. doi: 10.3171/jns.2003.98.5.0959.
PubMed 12744354Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. doi: 10.1161/01.STR.0000073841.88563.E9. Epub 2003 May 29.
PubMed 12775880Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Russin JJ, Partovi S, Nakaji P, Wallace RC. The Barrow Ruptured Aneurysm Trial: 6-year results. J Neurosurg. 2015 Sep;123(3):609-17. doi: 10.3171/2014.9.JNS141749. Epub 2015 Jun 26.
PubMed 26115467Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Nakaji P, Karis JP, Wallace RC. Ten-year analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial. J Neurosurg. 2019 Mar 8;132(3):771-776. doi: 10.3171/2018.8.JNS181846. Print 2020 Mar 1.
PubMed 30849758Campi A, Ramzi N, Molyneux AJ, Summers PE, Kerr RS, Sneade M, Yarnold JA, Rischmiller J, Byrne JV. Retreatment of ruptured cerebral aneurysms in patients randomized by coiling or clipping in the International Subarachnoid Aneurysm Trial (ISAT). Stroke. 2007 May;38(5):1538-44. doi: 10.1161/STROKEAHA.106.466987. Epub 2007 Mar 29.
PubMed 17395870Youssef PP, Dornbos Iii D, Peterson J, Sweid A, Zakeri A, Nimjee SM, Jabbour P, Arthur AS. Woven EndoBridge (WEB) device in the treatment of ruptured aneurysms. J Neurointerv Surg. 2021 May;13(5):443-446. doi: 10.1136/neurintsurg-2020-016405. Epub 2020 Jul 21.
PubMed 32719167
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE
- ClinicalTrials.gov ID
- NCT05171465
- Acronym / sponsor ID
- COVERAGE / PR(AG)564/2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Intrasaccular neck occlusion devices have been used for unruptured aneurysm without safety concerns and good occlusion rates. In the setting of a subarachnoid hemorrhage, they could improve the rate of complete occlusion without safety concerns.
Aim: To explore the safety and efficacy of intrasaccular neck occlusion devices in patients with acute subarachnoid hemorrhage caused by a ruptured saccular aneurysm by a one arm prospective registry.
Study outcome: The primary outcomes is the rate of complete occlusion (Raymond-Roy I) and rebleeding at one year follow-up. The primary safety outcome is rate of rebleeding during the admission.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVERAGE study is a multicentric and international study developed in high volume centers with previous experienced using intrasaccular neck occlusion devices. Patients that met all eligibility criteria are considered for enrolment. We include patients with SAH due to a ruptured intracranial saccular aneurysm and mild to moderate clinical symptoms (World Federation Neurological Surgeons ≤ III).
Key inclusion criteria (6 listed)
- Acute subarachnoid hemorrhage due to an intracranial ruptured aneurysm. Diagnosis must be done with acute CT or MRI.
- Intracranial saccular aneurysm with neck diameter 2-11mm and neck-dome height ≥2 mm.
- Clinical severity measured by World Federation Neurological Surgeons scale score ≤ III.
- Age ≥18 years.
- Previous modified Rankin scale ≤2.
Key exclusion criteria (6 listed)
- Hemodynamically unstable patients with requirement of advanced vital support.
- Patients with limited life expectancy (<6 months) due to terminal disease.
- Previous antiplatelet or anticoagulation treatment.
- Participation in any other clinical trial with a drug or device which could influence the outcome.
- Patients with neurological or psychiatric disease that could undermine future evaluations.
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 |
|---|---|---|
| Neqstent or ContourAll patients included will be treated the same: after catheterizing the affected vessel and microcatheterizing the aneurysm with a microcatheter of 0.021'' or 0.027'', the intrasaccular device (Neqstent® or Contour®) will be positioned. Depending of the operator preference, the use of an intrasaccular device could be associated with coiling (mandatory in the case of Neqstent®). Treatment must be performed without previous double antiplatelet treatment (allowing antiplatelet after aneurysm exclusion). Before the treatment all patients should undergo a flat panel CT. | Device | – |
Primary outcome
Efficacy achieving the lack of rebleeding
Time frame: 12 months
Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding
Efficacy achieving the complete occlusion
Time frame: 12 months
Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at 12 months follow-up evaluated by an image central core lab.
9 secondary outcomes
Analysis of the primary outcomes in different subgroups
Time frame: 12 months
Efficacy achieving the complete occlusion at end of treatment
Time frame: 1 day
Rate of patients who underwent the study treatment.
Time frame: 1 days
Rate of retreatment
Time frame: 12 months
Rate of mortality during admission or follow-up.
Time frame: 12 months
Functional outcome
Time frame: 12 months
Rate of vascular thrombosis or acute stroke.
Time frame: 12 months
Rate of early rebleeding.
Time frame: 30 days.
Rate of complications associated with the procedure.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 16139655Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5.
- Background: PubMed 19329361Molyneux AJ, Kerr RS, Birks J, Ramzi N, Yarnold J, Sneade M, Rischmiller J; ISAT Collaborators. Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol. 2009 May;8(5):427-33. doi: 10.1016/S1474-4422(09)70080-8. Epub 2009 Mar 28.
- Background: PubMed 12744354Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Vinuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. doi: 10.3171/jns.2003.98.5.0959.
- Background: PubMed 12775880Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. doi: 10.1161/01.STR.0000073841.88563.E9. Epub 2003 May 29.
- Background: PubMed 26115467Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Russin JJ, Partovi S, Nakaji P, Wallace RC. The Barrow Ruptured Aneurysm Trial: 6-year results. J Neurosurg. 2015 Sep;123(3):609-17. doi: 10.3171/2014.9.JNS141749. Epub 2015 Jun 26.
- Background: PubMed 30849758Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Nakaji P, Karis JP, Wallace RC. Ten-year analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial. J Neurosurg. 2019 Mar 8;132(3):771-776. doi: 10.3171/2018.8.JNS181846. Print 2020 Mar 1.
- Background: PubMed 17395870Campi A, Ramzi N, Molyneux AJ, Summers PE, Kerr RS, Sneade M, Yarnold JA, Rischmiller J, Byrne JV. Retreatment of ruptured cerebral aneurysms in patients randomized by coiling or clipping in the International Subarachnoid Aneurysm Trial (ISAT). Stroke. 2007 May;38(5):1538-44. doi: 10.1161/STROKEAHA.106.466987. Epub 2007 Mar 29.
- Background: PubMed 32719167Youssef PP, Dornbos Iii D, Peterson J, Sweid A, Zakeri A, Nimjee SM, Jabbour P, Arthur AS. Woven EndoBridge (WEB) device in the treatment of ruptured aneurysms. J Neurointerv Surg. 2021 May;13(5):443-446. doi: 10.1136/neurintsurg-2020-016405. Epub 2020 Jul 21.
- Individual participant dataSharing planned: Yes. Under reasoned request for metaanalysis or pooled data analysis
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by Hospital Universitari Vall d'Hebron Research Institute.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Tomasello, MD (934893000 ext. 6748, alejandrotomasello@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy achieving the lack of rebleeding (time frame: 12 months). The study lists 2 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 NCT05171465, which also lists 8 linked publications.
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 16 Feb 2022.