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The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular repair for aortoiliac or iliac aneurysms. | Device | Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients That Are Free From Patency-related Intervention | Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W. Anthony Lee, MD, FACS | Christine E. Lynn Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto HCS | Palo Alto | California | 94304 | United States | ||
| Stanford University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zenith® Iliac Branch System | Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Stanford |
| California |
| 94305 |
| United States |
| Christine E. Lynn Heart and Vascular Institute | Boca Raton | Florida | 33431 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercy Hospital East Communities | St Louis | Missouri | 63141 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Aurora St. Luke's Hospital | Milwaukee | Wisconsin | 53215 | United States |
| 6 Months |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zenith® Iliac Branch System | Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Patients That Are Free From Patency-related Intervention | Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms. | Of the 37 patients available for analysis at 6 months, data was available for 34 patients. | Posted | Number | participants | 6 Months |
|
|
|
180 days
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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 | Zenith® Iliac Branch System | Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™. | 0 | 40 | 7 | 40 | 7 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Spinal cord infarct | Nervous system disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Confusion | General disorders | Systematic Assessment |
| ||
| Non-Hodgkins lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Bursitis with overlying cellulitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Groin seroma | Surgical and medical procedures | Systematic Assessment |
| ||
| Groin hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder, PhD, Director of Clinical Affairs | Cook Research Incorporated | 765-463-7537 | Scott.Snyder@CookMedical.com |
| ID | Term |
|---|---|
| D017543 | Iliac Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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