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Investigational device is no longer manufactured
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visceral Manifold and Thoracic Bifurcation | Device | Endovascular stent graft system |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Modified Inclusion Criteria
A patient may be entered into the study if the patient has at least one of the following:
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:
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
Exclusion Criteria
General exclusion
Medical exclusion criteria
Anatomical exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| James H Black, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24997805 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Study Arm | 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. Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system Unitary Manifold: Endovascular stent graft system TAAA Debranching Stent Graft System: Endovascular stent graft system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2020 |
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| Unitary Manifold | Device | Endovascular stent graft system |
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| TAAA Debranching Stent Graft System | Device | Endovascular stent graft system |
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| FG001 | Expanded Selection Arm | 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. Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system Unitary Manifold: Endovascular stent graft system TAAA Debranching Stent Graft System: Endovascular stent graft system |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled patients who underwent staged/non-staged procedures were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Study Arm | 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. Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system Unitary Manifold: Endovascular stent graft system TAAA Debranching Stent Graft System: Endovascular stent graft system |
| BG001 | Expanded Selection Arm | 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. Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system Unitary Manifold: Endovascular stent graft system TAAA Debranching Stent Graft System: Endovascular stent graft system |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Enrolled patients with non-staged, completed procedures were analyzed. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | 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. | Enrolled patients with non-staged, completed procedures were analyzed. | Posted | Count of Participants | Participants | 1 year |
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1 year
Enrolled patients who received the study intervention were monitored and evaluated for Major Adverse Events (MAEs) and Serious Adverse Events (SAEs).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Study Arm | 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. Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system Unitary Manifold: Endovascular stent graft system TAAA Debranching Stent Graft System: Endovascular stent graft system | 2 | 2 | 1 | 2 | 0 | 2 |
| EG001 | Expanded Selection Arm | 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. Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system Unitary Manifold: Endovascular stent graft system TAAA Debranching Stent Graft System: Endovascular stent graft system | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bowel ischemia | Gastrointestinal disorders | Systematic Assessment |
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Enrollment is permanently closed because the investigational device is no longer manufactured. The target enrollment was not reached and there was insufficient power to measure the effect of the intervention.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James H. Black, III | Johns Hopkins University | (410) 955-5165 | jhblack@jhmi.edu |
| Jun 6, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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