Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE (COVERAGE)

February 1, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy achieving the lack of rebleeding
Time Frame: 12 months
Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding
12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the primary outcomes in different subgroups
Time Frame: 12 months
Analysis of the primary outcomes in different subgroups: anterior versus vertebrobasilar circulation, narrow versus wide (≥4mm) neck, aneurysm size (<10mm versus ≥10mm).
12 months
Efficacy achieving the complete occlusion at end of treatment
Time Frame: 1 day
Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at end of treatment.
1 day
Rate of patients who underwent the study treatment.
Time Frame: 1 days
Rate of patients who were included in the study and finally underwent the study treatment.
1 days
Rate of retreatment
Time Frame: 12 months
Rate of retreatment needed during the follow-up.
12 months
Rate of mortality during admission or follow-up.
Time Frame: 12 months
Rate of mortality during admission or follow-up.
12 months
Functional outcome
Time Frame: 12 months
Functional outcome at 12 months measured by modified Rankin scale.
12 months
Rate of vascular thrombosis or acute stroke.
Time Frame: 12 months
Rate of vascular thrombosis or acute stroke during follow-up.
12 months
Rate of early rebleeding.
Time Frame: 30 days.
Rate of early rebleeding during the admission.
30 days.
Rate of complications associated with the procedure.
Time Frame: 1 day
Rate of complications associated with the procedure.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)564/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Under reasoned request for metaanalysis or pooled data analysis

IPD Sharing Time Frame

From now to the end of the study

IPD Sharing Access Criteria

Under reasoned request for metaanalysis or pooled data analysis

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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