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| ID | Type | Description | Link |
|---|---|---|---|
| IDE G990139 | Other Identifier | FDA |
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The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suprarenal Proximal Cuff Extension | Device | Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Proximal Type I Endoleak | The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment. | Within 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Major Adverse Events | All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke | Within 30 days |
| Number of Participants With Stent Graft Integrity and Performance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Beasley, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| William M. Bogey, MD | East Carolina University Brody School of Medicine | Principal Investigator |
| Robert Feldman, MD | Munroe Regional Medical Center | Principal Investigator |
| Stuart Harlin, MD | Sacred Heart Hospital - Pensacola Research | Principal Investigator |
| Jeffrey Lawson, MD | Duke University | Principal Investigator |
| William Moore, MD | Lexington Medical Center | Principal Investigator |
| Charles Thompson, MD | Orlando Regional Medical Center | Principal Investigator |
| Thomas E. Topper, MD | Deaconess Hospital - The Heart Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States | ||
| Munroe Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16414382 | Background | Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025. | |
| 20831993 | Result | Harlin SA, Beasley RE, Feldman RL, Thompson CS, Williams JB. Endovascular abdominal aortic aneurysm repair using an anatomical fixation technique and concomitant suprarenal orientation: results of a prospective, multicenter trial. Ann Vasc Surg. 2010 Oct;24(7):921-9. doi: 10.1016/j.avsg.2010.05.008. |
| Label | URL |
|---|---|
| Sponsor Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Suprarenal Proximal Cuff Extension | Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All available data is reported
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Suprarenal Proximal Cuff Extension | Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Proximal Type I Endoleak | The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment. | Out of the 44 subjects enrolled 2 subjects withdrew even before reaching the 30day follow-up visit mark. Thus, 42 subjects were analyzed for the primary outcome. | Posted | Count of Participants | Participants | Within 30 Days |
|
2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years
Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non 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 | Suprarenal Proximal Cuff Extension | Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and Lymphatic Disorders | Blood and lymphatic system disorders | Custom Coding | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and Lymphatic System Disorder | Blood and lymphatic system disorders | Custom Coding | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisa Hebb, VP Clinical Affairs | Endologix | 949-598-4628 | ehebb@endologix.com |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| D057867 | Endoleak |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results |
| 30 days |
| Endoleak | Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak. Endoleak diagnosis results as reported by the Core Lab. | 30 days |
| Aneurysm Morphology Changes | Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab. | 30 days |
| Renal Function | Renal function as measured by serum creatinine. Laboratory results, | 30 days |
| Aneurysm Morphology Changes | Aneurysm morphology changes (Volume) as reported by CoreLab. | 30 days |
| Ocala |
| Florida |
| 34474 |
| United States |
| Orlando Regional Hospital | Orlando | Florida | 32806 | United States |
| Sacred Heart Hospital - Pensacola Research Consultants | Pensacola | Florida | 32504 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Deaconess Hospital - The Heart Group | Evansville | Indiana | 47710 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| East Carolina University - Brody School of Medicine | Greenville | North Carolina | 27834 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | For the purpose of this study, only Race was considered. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Ankle-Brachial Index(ABI) | The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | All available data has been reported | Mean | Standard Deviation | ratio |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Subjects With Major Adverse Events | All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke | All available data has been reported. | Posted | Count of Participants | Participants | Within 30 days |
|
|
|
| Secondary | Number of Participants With Stent Graft Integrity and Performance | Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results | All available data has been reported | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Endoleak | Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak. Endoleak diagnosis results as reported by the Core Lab. | All available data at 30 days is reported | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Aneurysm Morphology Changes | Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab. | All available data for 30 days has been reported | Posted | Mean | Standard Deviation | mm | 30 days |
|
|
|
| Secondary | Renal Function | Renal function as measured by serum creatinine. Laboratory results, | All available 30 day data has been reported. | Posted | Mean | Standard Deviation | mg/dL | 30 days |
|
|
|
| Secondary | Aneurysm Morphology Changes | Aneurysm morphology changes (Volume) as reported by CoreLab. | All available data for 30 days has been reported | Posted | Mean | Standard Deviation | cubic cm(cm^3) | 30 days |
|
|
|
| 3 |
| 44 |
| 11 |
| 44 |
| 12 |
| 44 |
| Cardiac Disorders | Cardiac disorders | Custom Coding | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Implant-Related Events | Product Issues | Custom Coding | Systematic Assessment |
|
| Musculoskeletal Disorders | Musculoskeletal and connective tissue disorders | Custom Coding | Systematic Assessment |
|
| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Other- SFA Rupture | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Respiratory Disorders | Respiratory, thoracic and mediastinal disorders | Custom Coding | Systematic Assessment |
|
| Supplemental Procedure | Surgical and medical procedures | Custom Coding | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | Custom Coding | Systematic Assessment |
|
| Endocrine disorders | Endocrine disorders | Custom Coding | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| General disorders | General disorders | Custom Coding | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | Custom Coding | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Custom Coding | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Custom Coding | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (inc cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Product issues | Product Issues | Custom Coding | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Custom Coding | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Custom Coding | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Custom Coding | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | Custom Coding | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | Custom Coding | Systematic Assessment |
|
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| D019106 |
| Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| Title | Measurements |
|---|---|
|
| Coronary Intervention |
|
| Myocardial Infarction |
|
| Renal Failure |
|
| Respiratory Failure |
|
| Secondary Procedure |
|
| Stroke |
|
| Title | Measurements |
|---|---|
|
| Stent Graft Migration |
|
| Title | Measurements |
|---|---|
|