Aortic DissectionNCT01568320

Zenith® Dissection Clinical Trial

A study testing Endovascular Treatment (Zenith) in people with Aortic Dissection, run by Cook Research Incorporated at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 24 sitesin 2 countries
Study dates: Aug 2012to 27 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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.

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States23 sites

University of Michigan Hospital
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cooper University Hospital
Camden, New Jersey, 08103
University of Virginia Medical Center
Charlottesville, Virginia, 22908
The Christ Hospital
Cincinnati, Ohio, 45219
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The Methodist Hospital
Houston, Texas, 77030
Indiana Heart Hospital
Indianapolis, Indiana, 46250
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
New York University Hospital
New York, New York, 10016
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Washington-Harborview Medical Center
Seattle, Washington, 98104
Barnes-Jewish Hospital
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Scott and White Hospital
Temple, Texas, 76508
University of Massachusetts
Worcester, Massachusetts, 01655

Other trials in United States

Japan1 site

Jikei University School of Medicine
Tokyo

Other trials in Japan

About this study

Official title: Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection

Conditions: Aortic Dissection
Being tested: Endovascular Treatment (Zenith)
Keywords: Aorta, Thoracic, Aortic dissection, Rupture, Type B, DeBakey type III, Endovascular
Medical subject headings: Aortic Dissection, Rupture

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.

Study groups in NCT01568320
Study group	Role	What they receive
Endovascular	Experimental	Endovascular Treatment (Zenith) Receives: Device: Endovascular Treatment (Zenith)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Freedom From Major Adverse Events
Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
Measured: 30 days
Survival Rate at 30 Days
Primary effectiveness endpoint is freedom from all cause mortality at 30 days
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201227 Jan 2020

First posted2 Apr 2012 (estimated)
Study startAug 2012
Primary completionFeb 2015
Study completion27 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01568320
Sponsor's protocol ID: 11-007
Status last verified: Feb 2021
First submitted: 29 Mar 2012
Last updated: 16 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Expanded access: Available

Publications

Lombardi JV, Gleason TG, Panneton JM, Starnes BW, Dake MD, Haulon S, Mossop PJ, Seale MM, Zhou Q; STABLE II Investigators. STABLE II clinical trial on endovascular treatment of acute, complicated type B aortic dissection with a composite device design. J Vasc Surg. 2020 Apr;71(4):1077-1087.e2. doi: 10.1016/j.jvs.2019.06.189. Epub 2019 Aug 30.
PubMed 31477479

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection

All Aortic Dissection trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
ClinicalTrials.gov ID: NCT01568320
Acronym / sponsor ID: 11-007
Conditions: Aortic Dissection
Keywords: Aorta, Thoracic, Aortic dissection, Rupture, Type B, DeBakey type III, Endovascular
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Cook Research IncorporatedIndustry (pharma, biotech, devices)
Study start: Aug 2012 (actual)
Primary completion: Feb 2015 (actual)
Study completion: 27 Jan 2020 (actual)
First posted: 2 Apr 2012 (estimated)
Results: Posted 16 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Endovascular	Experimental	Device: Endovascular Treatment (Zenith)Endovascular Treatment (Zenith)

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 (8 listed)

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;

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	Endovascular

Primary outcome

Number of Participants With Freedom From Major Adverse Events
Time frame: 30 days
Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
Survival Rate at 30 Days
Time frame: 30 days
Primary effectiveness endpoint is freedom from all cause mortality at 30 days

Results and safety

Results posted to the registry on 16 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endovascular	73	32

Primary outcome: Number of Participants With Freedom From Major Adverse Events

Time frame: 30 days. Number. Unit: participants

Measure	Endovascular n = 67
Value	48

Endovascular: Freedom from Major adverse events (%): 71.6 (95% CI 59 to 82)

Population analysed: In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment).Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1

Primary outcome: Survival Rate at 30 Days

Time frame: 30 days. Number. Unit: participants

Measure	Endovascular n = 67
Value	64

Endovascular: Survival rate (%): 95.5 (95% CI 87 to 99)

Population analysed: In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment). Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1

Adverse events

Time frame: 5-Year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endovascular	63 of 73 (86.3%)	40 of 73 (54.8%)	20 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31477479Lombardi JV, Gleason TG, Panneton JM, Starnes BW, Dake MD, Haulon S, Mossop PJ, Seale MM, Zhou Q; STABLE II Investigators. STABLE II clinical trial on endovascular treatment of acute, complicated type B aortic dissection with a composite device design. J Vasc Surg. 2020 Apr;71(4):1077-1087.e2. doi: 10.1016/j.jvs.2019.06.189. Epub 2019 Aug 30.

Related trials for Aortic Dissection

Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection

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.

Joseph Lombardi, MD principal investigator

The Cooper Health System

24 sites in 2 countries: 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 24 sites in 2 countries.

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 8 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: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Japan. 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?

Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Number of Participants With Freedom From Major Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01568320, which also lists 1 linked publication.

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 16 Mar 2021; AzTrials last refreshed its copy on 26 Oct 2026.