Thoracoabdominal Aortic AneurysmNCT03637374
Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
A study testing Visceral Manifold and Thoracic Bifurcation, Unitary Manifold and TAAA Debranching Stent Graft System in people with Thoracoabdominal Aortic Aneurysm, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- Visceral Manifold and Thoracic Bifurcation, Unitary Manifold and TAAA Debranching Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 6 Jun 2022
- 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
- Modified Inclusion Criteria
- A patient may be entered into the study if the patient has at least one of the following:
- An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
- Aneurysm with a history of growth > 0.5 cm in 6 months
- Saccular aneurysm deemed at significant risk for rupture
- Symptomatic aneurysm greater than 4.5 cm
Show all 17Show fewer
- Other inclusion criteria:
- Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
- Proximal landing zone for the thoracic bifurcation stent graft that has:
- ≥ 2.5 cm of healthy/nondiseased tissue (including previously placed graft material) (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
- ≥2.5cm of surgical graft distal to the left subclavian artery (LSA) diameter in the range of 26-42mm.
- Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
- Minimum branch vessel diameter greater than 5 mm
- Iliac artery distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
- Patency of the four major visceral vessels (SMA, celiac, right renal, left renal)
- Age: ≥ 18 years old
- Life expectancy: > 1 year
Who cannot join
- General exclusion
- Patient is a good candidate for and elects open surgical repair
- Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored investigational device exemption (IDE) at the investigational site
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent by patient or legal representative
Show all 26Show fewer
- Patient is pregnant or breastfeeding
- Patient has a contained rupture
- Patient has a ruptured aneurysm
- Patient has a dissection in the treated portion of the aorta
- Obstructive stenting of any or all of the visceral vessels
- Medical exclusion criteria
- Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
- Uncorrectable coagulopathy
- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
- Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair
- Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
- Systemic or local infection that may increase the risk of endovascular graft infection
- Baseline creatinine greater than 2.0 mg/dL
- History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
- Anatomical exclusion criteria
- Thrombus or excessive calcification within the neck of the aneurysm
- Branch stenosis ≥ 70%
- Anatomy that would not allow maintenance of at least one patent hypogastric artery
- Anatomy that would not allow primary or assisted patency of the left subclavian artery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Read the detailed description
The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- Visceral Manifold and Thoracic Bifurcation, Unitary Manifold, TAAA Debranching Stent Graft System
- Keywords
- aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral Manifold and Thoracic BifurcationDevice
Endovascular stent graft system
Unitary ManifoldDevice
Endovascular stent graft system
TAAA Debranching Stent Graft SystemDevice
Endovascular stent graft system
| Study group | Role | What they receive |
|---|---|---|
| Primary Study Arm | Experimental | The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. Receives: Device: Visceral Manifold and Thoracic Bifurcation; Device: Unitary Manifold; Device: TAAA Debranching Stent Graft System |
| Expanded Selection Arm | Other | The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. Receives: Device: Visceral Manifold and Thoracic Bifurcation; Device: Unitary Manifold; Device: TAAA Debranching Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Major Adverse Events (MAEs) at 30 Days
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Measured: 30 days
Secondary outcomes (1)
Treatment Success at 1 Year
Treatment success is defined as a composite of technical success and freedom from the following:
Aneurysm enlargement, Aneurysm rupture, Aneurysm-related mortality, Conversion to open repair, Secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start8 Sep 2020
- Primary completion21 Mar 2022
- Study completion6 Jun 2022
Why it stopped: Investigational device is no longer manufactured
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 Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James H Black, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637374
- Sponsor's protocol ID
- IRB00075706
- Status last verified
- Jul 2022
- First submitted
- 10 Aug 2018
- Last updated
- 19 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.
PubMed 24997805
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
- ClinicalTrials.gov ID
- NCT03637374
- Acronym / sponsor ID
- IRB00075706
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Keywords
- aortic aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational device is no longer manufactured
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Posted 19 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Detailed description
The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Study Arm | Experimental | Device: Visceral Manifold and Thoracic Bifurcation, Device: Unitary Manifold, Device: TAAA Debranching Stent Graft SystemThe TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. |
| Expanded Selection Arm | Other | Device: Visceral Manifold and Thoracic Bifurcation, Device: Unitary Manifold, Device: TAAA Debranching Stent Graft SystemThe Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Modified Inclusion Criteria
- An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
- Aneurysm with a history of growth > 0.5 cm in 6 months
- Saccular aneurysm deemed at significant risk for rupture
- Symptomatic aneurysm greater than 4.5 cm
Key exclusion criteria (26 listed)
- General exclusion
- Patient is a good candidate for and elects open surgical repair
- Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored investigational device exemption (IDE) at the investigational site
- Unwilling to comply with the follow-up schedule
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 |
|---|---|---|
| Visceral Manifold and Thoracic BifurcationEndovascular stent graft system | Device | Expanded Selection Arm, Primary Study Arm |
| Unitary ManifoldEndovascular stent graft system | Device | Expanded Selection Arm, Primary Study Arm |
| TAAA Debranching Stent Graft SystemEndovascular stent graft system | Device | Expanded Selection Arm, Primary Study Arm |
Primary outcome
Freedom From Major Adverse Events (MAEs) at 30 Days
Time frame: 30 days
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
1 secondary outcome
Treatment Success at 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24997805Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.
- Individual participant dataSharing planned: No
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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.
James H Black, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral Manifold and Thoracic Bifurcation, Unitary Manifold and TAAA Debranching Stent Graft System in people with Thoracoabdominal Aortic Aneurysm, run by Johns Hopkins University at 1 site 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 17 inclusion and 26 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: stopped early, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Aug 2022). 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?
Freedom From Major Adverse Events (MAEs) 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 NCT03637374, 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 19 Aug 2022.