Trial on Endovascular Aneurysm Management

Centre hospitalier de l'Université de Montréal (CHUM)80 enrolled

Overview

The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.

This study is designed as a pragmatic trial. All candidates for endovascular treatment of one or more unruptured intracranial aneurysms will be offered to participate. Unruptured aneurysms may be recently discovered or prevalent. If they accept, subjects will be randomized to one of the two arms of the trial: Conservative management (Observation) or Endovascular treatment. Both groups will be advised to obtain medical treatment for hypertension if necessary and will receive counselling for behavioural risk factor modelling (smoking or excessive drinking) when indicated. A non-invasive (MRA or CTA) or catheter angiogram and a baseline CT-scan or MRI of the brain are required to enter the study. These studies should demonstrate the unequivocal presence of a saccular aneurysm \>=3 mm treatable by endovascular methods. A catheter angiogram is required if there is doubt. Imaging studies will be reviewed centrally. Both treatments will be standardized. Patients will be followed similarly for a minimum of 10 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Brain Aneurysm

Interventions

Embolization, coilingDEVICE

Endovascular embolization with platinum coils

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least one documented subarachnoid aneurysm, never ruptured * Patient aged 18 or older * Life expectancy more than 10 years Exclusion Criteria: * Patients with recent (less than 3 months) intracranial haemorrhage * Lesion characteristics unsuitable for endovascular treatment * Patients with a single extradural aneurysm * Aneurysms \< 3 mm or giant aneurysms (≥ 25 mm) * Patients with a poor outcome (Rankin scale ≥ 3) after the rupture, surgical or endovascular treatment of another aneurysm * Patients with incompletely treated aneurysms that have previously ruptured * Patients with associated arteriovenous malformations * Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect) * Patients with previous intracranial haemorrhage from unknown etiology * Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management * Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium * Pregnant patients * Patients unable to give informed consent

Locations (9)

St Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Boston Medical Center

Boston, Massachusetts, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

Outcomes

Primary Outcomes

Number of Participants With Disease or Treatment-related Morbidity and Mortality.

Morbidity or mortality is evaluated using the modified Rankin Scale (mRS) which goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process. a "Good" Primary Outcome was categorized from mRS scores of 0, 1, or 2. a "Bad" Primary Outcome was categorized from mRS scores of 3, 4, 5 or 6.

Time frame: 1 year after treatment or observation

Secondary Outcomes

Rate of Hemorrhage in Conservative Group

To better define the natural history of unruptured aneurysms eligible for endovascular treatment.

Time frame: At 5 and 10 years

Number of Participants With Hemorrhage in Endovascular Group

Number of participants experiencing a hemorrhagic event despite successful treatment. This outcome measure gives an estimate of risk of rupture despite treatment

Time frame: At 1 year

Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group

The modified Rankin Scale (mRS) goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process. The number of participants having in each score is given.

Time frame: At 1 year

Modified Rankin Score

To compare overall Morbidity/Mortality of the 2 groups

Time frame: At 10 years

Measures on 36-Item Short-Form Health Survey (SF-36)

To compare the quality of life and anxiety levels of surviving patients of the 2 groups according to the SF-36 questionnaire minimum is 0 (maximum disability) maximum is 100 (No disability)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.