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Study of anatomical fixation with a 34mm proximal extension
The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Powerlink 34mm cuff stent graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endologix Powerlink 34 mm stent graft cuff | Device | Endovascular abdominal aortic aneurysm repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Proximal Type I Endoleak at Each Timepoint | Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months). | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Delivery and Deployment of the Device | Successful delivery and deployment of the device with no complication. | 1 Month |
| Number of Participants With Type III Endoleaks at Each Timepoint |
Not provided
Inclusion Criteria:
18 years old or older
Informed consent understood and signed
Will comply with protocol follow-up requirements
Candidate for conventional open surgical repair
Aneurysm outer diameter is one or more of the following:
Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
Iliac artery internal diameter greater than or equal to 8 mm
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Y Woo, MD | Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States | Principal Investigator |
| O. W. Brown, MD | William Beaumont Hospital, Royal Oak, MI 48073, United States | Principal Investigator |
| James G. Melton, DO | Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States | Principal Investigator |
| Steven H. Tyndall, MD | Nebraska Heart Hospital, Lincoln, NE 68526, United States | Principal Investigator |
| William M. Moore, MD | Lexington Medical Center, West Columbia, SC 29169, United States | Principal Investigator |
| Salem George, MD | Baptist Hospital East, Louisville, KY 40207, United States | Principal Investigator |
| Kerry C. Prewitt, MD | St. Joseph Medical Center, Towson, MD 21204, United States | Principal Investigator |
| Paul Anain, MD | Sisters of Charity Hospital, Buffalo, NY 14214, United States | Principal Investigator |
| Robert Beasley, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | Miami | Florida | 33140 | United States | ||
| Baptist Cardiac and Vascular Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19679425 | Result | Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, Carpenter JP; Endologix Investigators. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg. 2009 Nov;50(5):979-86. doi: 10.1016/j.jvs.2009.05.057. Epub 2009 Aug 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Powerlink 34mm cuff stent graft Endologix Powerlink 34 mm stent graft cuff: Endovascular abdominal aortic aneurysm repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants received a commercially available 28mm Powerlink infrarenal bifurcated stent graft and a 34mm infrarental proximal cuff
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy | Powerlink 34mm cuff stent graft Endologix Powerlink 34 mm stent graft cuff: Endovascular abdominal aortic aneurysm repair |
| 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 Participants With Proximal Type I Endoleak at Each Timepoint | Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months). | Posted | Count of Participants | Participants | Five years |
|
|
Up to 5 Years
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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 | Powerlink 34mm Cuff Stent Graft | Powerlink 34mm cuff stent graft Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Custom Coding | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Custom Coding | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharone Trifskin | Endologix | 949-599-8860 | strifskin@endologix.com |
Not provided
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
| 5 Years |
| Number of Participants With Stent Fracture at Each Timepoint | Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab. | 5 Years |
| Number of Participants With Stent Graft Obstruction at Each Timepoint | Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab. | 5 Years |
| Number of Participants With Migration at Each Timepoint | Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab. | 5 Years |
| Number of Participants With Type II Endoleaks at Each Timepoint | Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab. | 5 Years |
| Number of Participants With Aneurysm Diameter Change at Each Timepoint | Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab. | 5 Years |
| Maximum Diameter Measurements | Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months). | 5 Years |
| Aneurysm Volume Measurements | Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab. | 5 Years |
| Mount Sinai Medical Center, Miami Beach, FL 33140, United States |
| Principal Investigator |
| Barry T. Katzen, MD | Baptist Cardiac and Vascular Institute, Miami, FL 33176, United States | Principal Investigator |
| Miami |
| Florida |
| 33176 |
| United States |
| Baptist Hospital East | Louisville | Kentucky | 40207 | United States |
| St. Joseph Medical Center | Towson | Maryland | 21204 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | United States |
| Sisters of Charity Hospital | Buffalo | New York | 14214 | United States |
| Oklahoma Cardiovascular Associates | Oklahoma City | Oklahoma | 73120 | United States |
| Hospital at the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Medical History | Count of Participants | Participants |
|
| Aneurysm Diameter Distribution | Count of Participants | Participants |
|
| Mean Aneurysm Measurements | Mean | Standard Deviation | mm |
|
|
| Secondary | Number of Participants With Successful Delivery and Deployment of the Device | Successful delivery and deployment of the device with no complication. | Posted | Count of Participants | Participants | 1 Month |
|
|
|
| Secondary | Number of Participants With Type III Endoleaks at Each Timepoint | Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab. | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Count of Participants | Participants | 5 Years |
|
|
|
| Secondary | Number of Participants With Stent Fracture at Each Timepoint | Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab. | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Count of Participants | Participants | 5 Years |
|
|
|
| Secondary | Number of Participants With Stent Graft Obstruction at Each Timepoint | Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab. | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Count of Participants | Participants | 5 Years |
|
|
|
| Secondary | Number of Participants With Migration at Each Timepoint | Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab. | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Count of Participants | Participants | 5 Years |
|
|
|
| Secondary | Number of Participants With Type II Endoleaks at Each Timepoint | Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab. | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Count of Participants | Participants | 5 Years |
|
|
|
| Secondary | Number of Participants With Aneurysm Diameter Change at Each Timepoint | Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab. | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Count of Participants | Participants | 5 Years |
|
|
|
| Secondary | Maximum Diameter Measurements | Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months). | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Mean | Standard Deviation | mm | 5 Years |
|
|
|
| Secondary | Aneurysm Volume Measurements | Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab. | Results are provided as the number of events over the number of patients with the follow-up image available. | Posted | Mean | Standard Deviation | cm3 | 5 Years |
|
|
|
| 6 |
| 19 |
| 14 |
| 19 |
| 7 |
| 19 |
| Decreased Hematocrit | Blood and lymphatic system disorders | Custom Coding | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Custom Coding | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Custom Coding | Systematic Assessment |
|
| MI | Cardiac disorders | Custom Coding | Systematic Assessment |
|
| Triple Vessel Coronary Artery Disease | Cardiac disorders | Custom Coding | Systematic Assessment |
|
| Cholecystis | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Erosive Gastritis/Epgastric Pain | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| GI Bleeding | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Vomiting, Diarrhea, Dehydration | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Increased Ascites secondary to cirrhosis | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Lieus | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Pseudomembraneous colitis | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Death | General disorders | Custom Coding | Systematic Assessment |
|
| Non cardiac CP | General disorders | Custom Coding | Systematic Assessment |
|
| Abdominal Pain | General disorders | Custom Coding | Systematic Assessment |
|
| Left groin incision infection | Infections and infestations | Custom Coding | Systematic Assessment |
|
| MRSA left lower leg | Infections and infestations | Custom Coding | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Custom Coding | Systematic Assessment |
|
| Compression Fracture of Lumbar Spine | Musculoskeletal and connective tissue disorders | Custom Coding | Systematic Assessment |
|
| Umbilical Hernia | Musculoskeletal and connective tissue disorders | Custom Coding | Systematic Assessment |
|
| Brain Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Metastatic Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Metastatic Brain tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Side branch-type pancreatic papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Stage IV small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Left lower lung mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom Coding | Systematic Assessment |
|
| Endoleak with Increased aneurysm | Product Issues | Custom Coding | Systematic Assessment |
|
| Limb extension right distal leak | Product Issues | Custom Coding | Systematic Assessment |
|
| Type I endoleak requiring endovascular repair | Product Issues | Custom Coding | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Custom Coding | Systematic Assessment |
|
| Major depression recurrent | Psychiatric disorders | Custom Coding | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Custom Coding | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Custom Coding | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Custom Coding | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Custom Coding | Systematic Assessment |
|
| Right leg ulcer and tingling | Skin and subcutaneous tissue disorders | Custom Coding | Systematic Assessment |
|
| Translumbar embolization of AAA sac | Surgical and medical procedures | Custom Coding | Systematic Assessment |
|
| Aneurysm increased >/=5mm | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Coagulopathy: decreased platelets due to HIT+ | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Ischemic Left Leg | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Left femoral-popliteal bypass with graft | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Right femoral tibial bypass for gangrenous foot | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Vision problems | Eye disorders | Custom Coding | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Postop ileus | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Peri rectal abscess | Gastrointestinal disorders | Custom Coding | Systematic Assessment |
|
| Burning down left anterior leg | General disorders | Custom Coding | Systematic Assessment |
|
| Chest pain | General disorders | Custom Coding | Systematic Assessment |
|
| Fatigue | General disorders | Custom Coding | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Custom Coding | Systematic Assessment |
|
| Mild erythema left knee | Musculoskeletal and connective tissue disorders | Custom Coding | Systematic Assessment |
|
| Right inguinal hernia | Musculoskeletal and connective tissue disorders | Custom Coding | Systematic Assessment |
|
| Endoleak Type I distal | Product Issues | Custom Coding | Systematic Assessment |
|
| Endoleak Type II IMA | Product Issues | Custom Coding | Systematic Assessment |
|
| Left distal endoleak | Product Issues | Custom Coding | Systematic Assessment |
|
| Type I endoleak | Product Issues | Custom Coding | Systematic Assessment |
|
| Type I endoleak - placement aortic stent | Product Issues | Custom Coding | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Custom Coding | Systematic Assessment |
|
| Lung nodule | Respiratory, thoracic and mediastinal disorders | Custom Coding | Systematic Assessment |
|
| Pulmonary congestion postop | Respiratory, thoracic and mediastinal disorders | Custom Coding | Systematic Assessment |
|
| Severe Pulmonary Enphisema | Respiratory, thoracic and mediastinal disorders | Custom Coding | Systematic Assessment |
|
| ABO Sugical Incisional Pain | Surgical and medical procedures | Custom Coding | Systematic Assessment |
|
| Incisional pain | Surgical and medical procedures | Custom Coding | Systematic Assessment |
|
| Left groin bleed | Surgical and medical procedures | Custom Coding | Systematic Assessment |
|
| Removal of sternal wire - non healing | Surgical and medical procedures | Custom Coding | Systematic Assessment |
|
| Carotid endoarterectomy | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Carotid Stenosis | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Elevated velocity left internal carotid | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Hypotension | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Renal Artery stenosis | Vascular disorders | Custom Coding | Systematic Assessment |
|
| Increased Creatinine | Renal and urinary disorders | Custom Coding | Systematic Assessment |
|
Not provided
| D001018 |
| Aortic Diseases |
|
| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| 6 Months |
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| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| 12 Months |
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| 48 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| Increase |
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| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| 6 Months |
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