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States

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Treatment for Aneurysm

Phase-Based Progress Estimates

3

Effectiveness

3

Safety

Baptist Health, Jacksonville, FL

Aneurysm+2 More

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18+

All Sexes

Eligible conditions

Select

Eligibility

18+

All Sexes

Eligible conditions

Select

Study Summary

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

See full description

Eligible Conditions

Aneurysm
Intracranial Aneurysms

Treatment Effectiveness

Effectiveness Estimate

3 of 3

This is better than 93% of similar trials

Compared to trials

1

Antibiotic Irrigation

3

Yellow Fever Vaccine

1

PMEG

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

Compared to trials

1

Antibiotic Irrigation

3

Yellow Fever Vaccine

1

PMEG

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.

Yes

No

Unsure

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.

Yes

No

Unsure

Saccular morphology

Yes

No

Unsure

Located at a bifurcation in the anterior or posterior circulation

Yes

No

Unsure

Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm

Yes

No

Unsure

Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio < 2

Yes

No

Unsure

Patient may be treated with Contour without the use of additional implanted devices.

Yes

No

Unsure

Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.

Yes

No

Unsure

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.

Yes

No

Unsure

FOR PATIENTS WITH UNRUPTURED ANEURYSM

Yes

No

Unsure

Patient Q&A Section

Ask a question about the study

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.

Treatment for Aneurysm

Study Summary

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

Eligible Conditions

Treatment Effectiveness

Effectiveness Estimate

Compared to trials

Study Objectives

Trial Safety

Safety Estimate

Compared to trials

Trial Design

0 Treatment Group

Trial Logistics

Trial Timeline

Closest Location

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.

Patient Q&A Section

Ask a question about the study

Other questions from users

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

Will my insurance cover participating in this trial?

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Endovascular Neurosurgeryfor Aneurysm Cerebral (Unruptured)

Valiant Thoracoabdominal Stent Graft Systemfor Thoracoabdominal Aortic Aneurysms

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Behavioral Testing Under Intracranial Monitoringfor Cognition

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