CompletedNot Applicable

Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection

Australia, Czechia, France60 participantsStarted 2007-12

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

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.

Inclusion Criteria: * Branch vessel obstruction/compromise * Peri-aortic effusion/hematoma * Resistant hypertension * Persistent pain/symptoms * Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm) Exclusion Criteria: * Age less than 18 years * Frank rupture * Diagnosed or suspected congenital degenerative connective tissue disease * Systemic infection * Untreatable reaction to contrast * Surgical/endovascular AAA repair within 30 days * Previous placement of thoracic endovascular graft * Prior repair of descending thoracic aorta * Interventional/open procedures within 30 days * Onset of symptoms \> 3 months

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

The primary endpoint is survival at 30 days

Timeframe: 30 days

Trial details

NCT IDNCT00526487

SponsorWilliam Cook Europe

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07

View on ClinicalTrials.gov More Aortic Dissection Involving the Descending Thoracic Aorta trials

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.