Treatment for Aneurysm

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Baptist Health, Jacksonville, FL
Aneurysm+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

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Eligible Conditions

  • Aneurysm
  • Intracranial Aneurysms

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 4 primary outcomes and 2 secondary outcomes in patients with Aneurysm. Measurement will happen over the course of 30 days.

1 year
Key Secondary Effectiveness Endpoint
Key Secondary Effectiveness Endpoint: The trial's secondary endpoint is the proportion of subjects with angiographic aneurysmal recurrence defined as aneurysm growth or recanalization at one (1) year after treatment.
Primary Effectiveness Endpoint
Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.
30 days
Primary Safety Endpoint
Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

0 Treatment Group

This trial requires 220 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Baptist Health - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient is 18-75 years of age at the time of screening.
Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
Saccular morphology
Located at a bifurcation in the anterior or posterior circulation
Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm
Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio < 2
Patient may be treated with Contour without the use of additional implanted devices.
Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written informed consent prior to initiation of any study procedures.
FOR PATIENTS WITH UNRUPTURED ANEURYSM

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Aneurysm by sharing your contact details with the study coordinator.