Aortic Dissection Involving the Descending Thoracic AortaNCT00526487
Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection
A study testing Zenith® Dissection Endovascular System and Endovascular Repair in people with Aortic Dissection Involving the Descending Thoracic Aorta, run by William Cook Europe at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection Involving the Descending Thoracic Aorta
- What is being tested?
- Zenith® Dissection Endovascular System and Endovascular Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Dec 2007to Sep 2016
- Phase
- Interventional
- 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
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Previous placement of thoracic endovascular graft
- Prior repair of descending thoracic aorta
- Interventional/open procedures within 30 days
- Onset of symptoms > 3 months
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Germany3 sites
Hannover Medical School
Hanover, 30625
Heart Center Leipzig / Park Hospital
Leipzig, 04289
Clinic of Internal Medicine, University Hospital Rostock
Rostock, 18057
Italy2 sites
Hospital San Raffaele
Milan, 20129
IRCCS Policlinico San Matteo
Pavia, 27100
About this study
Official title: Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta
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.
Read the detailed description
The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
- Being tested
- Zenith® Dissection Endovascular System, Endovascular Repair
- Keywords
- Thoracic Dissection, Dissection, Endovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® Dissection Endovascular SystemDevice
The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
Endovascular RepairDevice
Endovascular Repair
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Endovascular Repair Receives: Device: Zenith® Dissection Endovascular System; Device: Endovascular Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is survival at 30 days
Measured: 30 days
Secondary outcomes (1)
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2011
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Dissection Involving the Descending Thoracic AortaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Cook Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cook Group Incorporated, MED Institute, Incorporated, William Cook Australia
- Responsible party
- Sponsor
- Investigators
- Joseph Lombardi, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526487
- Sponsor's protocol ID
- 07-004
- Other IDs
- 370010, TXD
- Status last verified
- Feb 2017
- First submitted
- 5 Sep 2007
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.
PubMed 31147139
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta
- ClinicalTrials.gov ID
- NCT00526487
- Acronym / sponsor ID
- 07-004
- Keywords
- Thoracic Dissection, Dissection, Endovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- William Cook EuropeIndustry (pharma, biotech, devices)
- Collaborators
- Cook Group Incorporated, MED Institute, Incorporated, William Cook Australia
- Study start
- Dec 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Sep 2007 (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 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.
Detailed description
The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Zenith® Dissection Endovascular System, Device: Endovascular RepairEndovascular Repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- Age less than 18 years
- Frank rupture
- Diagnosed or suspected congenital degenerative connective tissue disease
- Systemic infection
- Untreatable reaction to contrast
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 |
|---|---|---|
| Zenith® Dissection Endovascular SystemThe Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta. | Device | 1 |
| Endovascular RepairEndovascular Repair | Device | 1 |
Primary outcome
The primary endpoint is survival at 30 days
Time frame: 30 days
1 secondary outcome
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Derived from this study: PubMed 31147139Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.
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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.
Joseph Lombardi, MD principal investigator
Thomas Jefferson University
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith® Dissection Endovascular System and Endovascular Repair in people with Aortic Dissection Involving the Descending Thoracic Aorta, run by William Cook Europe at 8 sites in 5 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 5 inclusion and 10 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Italy, Australia, Czechia, France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is survival at 30 days (time frame: 30 days). 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 NCT00526487, 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 1 Mar 2017.