Aortic DissectionNCT02464943
Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections
A study testing Endovascular Treatment (Zenith) in people with Aortic Dissection, run by Cook Research Incorporated at 3 sites in United States.
Trial summary
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Endovascular Treatment (Zenith)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- < 18 years of age
- Other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., < 2 years)
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Unwilling to 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cooper University Hospital
Camden, New Jersey, 08103
University of Virginia Medical Center
Charlottesville, Virginia, 22908
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissections
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
- Conditions
- Aortic Dissection
- Being tested
- Endovascular Treatment (Zenith)
- Keywords
- Aorta, Thoracic, Aortic dissection, Type B, DeBakey type III, Endovascular
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Treatment (Zenith)Device
Also called Endovascular graft, Endovascular stent, Stent-graft
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464943
- Sponsor's protocol ID
- 11-007-CA
- Status last verified
- Jan 2020
- First submitted
- 3 Jun 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissections
- ClinicalTrials.gov ID
- NCT02464943
- Acronym / sponsor ID
- 11-007-CA
- Conditions
- Aortic Dissection
- Keywords
- Aorta, Thoracic, Aortic dissection, Type B, DeBakey type III, Endovascular
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- < 18 years of age
- Other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., < 2 years)
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Unwilling to unable to comply with the follow-up schedule
- Inability or refusal to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Treatment (Zenith)Also: Endovascular graft, Endovascular stent, Stent-graftInstead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Treatment (Zenith) in people with Aortic Dissection, run by Cook Research Incorporated at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.