An interventional study of Visceral Manifold and Thoracic Bifurcation and Unitary Manifold in Thoracoabdominal Aortic Aneurysm, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 2 is below the median of 72 across 462 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Modified Inclusion Criteria
A patient may be entered into the study if the patient has at least one of the following:
Other inclusion criteria:
Proximal landing zone for the thoracic bifurcation stent graft that has:
Exclusion Criteria
General exclusion
Medical exclusion criteria
Anatomical exclusion criteria
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.
Device: Visceral Manifold and Thoracic Bifurcation · Device: Unitary Manifold · Device: TAAA Debranching Stent Graft System
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.
Device: Visceral Manifold and Thoracic Bifurcation · Device: Unitary Manifold · Device: TAAA Debranching Stent Graft System
Endovascular stent graft system
Endovascular stent graft system
Endovascular stent graft system
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.
Time frame: 30 days
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.
Time frame: 1 year
| Milestone | Primary Study Arm | Expanded Selection Arm |
|---|---|---|
| Started | 2 | 0 |
| Completed | 0 | 0 |
| Not completed | 2 | 0 |
| Withdrew: Death | 2 | 0 |
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
| Participants | Primary Study Arm | Expanded Selection Arm |
|---|---|---|
| Freedom From Major Adverse Events (MAEs) at 30 Days | 1 | 0 |
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.
| Participants | Primary Study Arm | Expanded Selection Arm |
|---|---|---|
| Treatment Success at 1 Year | 0 | 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Study Arm | 2/2 (100%) | 1/2 (50%) | 0/2 (0%) |
| Expanded Selection Arm | — | — | — |
| Event | Primary Study Arm | Expanded Selection Arm |
|---|---|---|
| bowel ischemiaGastrointestinal disorders | 1/2 | — |
Enrolled patients who underwent staged/non-staged procedures were analyzed.
| Age, Categorical(Participants) | Primary Study Arm | Expanded Selection Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | Primary Study Arm | Expanded Selection Arm | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 2 | 0 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Primary Study Arm | Expanded Selection Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Primary Study Arm | Expanded Selection Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 0 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Primary Study Arm | Expanded Selection Arm | Total |
|---|---|---|---|
| United States | 2 | 0 | 2 |
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