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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 3264 | Other Identifier | Cleveland Clinic IRB |
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The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.
This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Aneurysm Repair | Experimental | Investigational stent-graft implant to exclude aneurysm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Aneurysm Repair | Device | Endovascular exclusion of aneurysm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Aneurysm Rupture | Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Eagleton, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28502545 | Derived | Farivar BS, Abbasi MN, Dias AP, Kuramochi Y, Brier CS, Parodi FE, Eagleton MJ. Durability of iliac artery preservation associated with endovascular repair of infrarenal aortoiliac aneurysms. J Vasc Surg. 2017 Oct;66(4):1028-1036.e18. doi: 10.1016/j.jvs.2017.02.042. Epub 2017 May 11. | |
| 24188715 | Derived | Eagleton MJ, Shah S, Petkosevek D, Mastracci TM, Greenberg RK. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. 2014 Jan;59(1):89-94. doi: 10.1016/j.jvs.2013.07.007. Epub 2013 Nov 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endovascular Aneurysm Repair | Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endovascular Aneurysm Repair | Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Aneurysm Rupture | Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan | Posted | Count of Participants | Participants | 2 years |
|
|
At discharge, 1-, 6-, 12- and 24-month.
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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 | Endovascular Aneurysm Repair | Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm Growth | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm Growth | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Eagleton, MD | Massachusetts General Hospital | 617-726-8279 | meagleton@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 4, 2002 | Jan 18, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D017543 | Iliac Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Presence of AAA or Iliac Aneurysm | Number | participants |
|
|
| 292 |
| 401 |
| 9 |
| 401 |
| 9 |
| 401 |
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| D001018 |
| Aortic Diseases |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |