CompletedNot Applicable

Zenith® Dissection Clinical Trial

United States, Japan73 participantsStarted 2012-08

Plain-language summary

The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Age \< 18 years;
. Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
. Unwilling or unable to comply with the follow-up schedule;
. Inability or refusal to give informed consent;
. Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);
. Additional medical restrictions as specified in the Clinical Investigation Plan; or
. Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Freedom From Major Adverse Events

Timeframe: 30 days

Survival Rate at 30 Days

Timeframe: 30 days

Trial details

NCT IDNCT01568320

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2021-01-29

View on ClinicalTrials.gov More Aortic Dissection trials