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This study is a multi-center prospective, open label, non-randomized investigation of INCRAFTâ„¢ in subjects with abdominal aortic aneurysms.
The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFTâ„¢ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects at 7 sites in Germany and Italy. All treated subjects will be evaluated at 1 month, 3 months (if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. An interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAA stent graft system | Experimental | Cordis AAA stent graft system "INCRAFT TM" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordis AAA stent graft system "INCRAFT TM" | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Technical Success Through the One Month Follow up. | Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up. | From procedure to one month follow up |
| Rate of Primary Safety Endpoint Within 1 Month Post-procedure. | Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure. | One month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure. | Incidence of aneurysm enlargement annually through 5 years post - procedure. Aneurysm enlargement is defined as being compared to the 30 day baseline assessment. | Day 30 through year 5 post-procedure |
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INCLUSION CRITERIA:
Subject is a male or infertile female > 18 years of age
Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures.
Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
Subject has at least one of the following:
Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr
Subject aortic aneurysm neck is ≥15 mm in length
Subject iliac landing zone≥10mm in length
Subject has distal iliac landing sites with diameter ranges of 9-18mm
Subject proximal aortic attachment is between 20-27 mm in diameter.
Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm.
Subject is willing to comply with all specified follow-up evaluations.
EXCLUSION CRITERIA:
Subject has one of the following:
The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis
Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm
Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones
Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta
Subject has aneurysm neck angulations that are >60° in the supra-renal and/or infra-renal locations
Aortic bifurcation ≤18mm in diameter
Acute vascular injury due to trauma
Subject has a known allergy to contrast medium
Subject has known allergy to nitinol, PET or PTFE
Subject has a need for emergent surgery
Subject has a contraindication to undergoing angiography
Subject has a thoracic aortic aneurysm that requires treatment
Subject has Infra-renal aortic dissection
Subject has an Iliac anatomy which would require occlusion of both internal iliac arteries
Subject has congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated (e.g. angiography or CT) prior to treatment
Subject has unstable angina as defined by Braunwald angina classification
Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely inhibit visualization of the aorta
Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome)
Subject has known bleeding or hypercoagulable disorder
Subject has contraindication for anticoagulation
Subject with Stroke or MI or intracranial bleeding within 3 months prior to the procedure
Subject with renal insufficiency (creatinine > 2.0 mg/dl)
Subject has known or suspected active infection at the time of the index procedure (for ex. Pneumonia, acute virus infection, contaminated wounds etc)
Subject is currently taking systemic immunosuppressant therapy
Subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure
Subject has a life expectancy less than 2 years
Subject is currently participating in another research study involving an investigational device or new drug
Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment
Subject with an existing AAA surgical graft and/or a AAA stent-graft system
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| Name | Affiliation | Role |
|---|---|---|
| Dierk Scheinert, PhD, MD. | Universität Leipzig - Herzzentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Leipzig Herzzentrum | Leipzig | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332982 | Background | Scheinert D, Pratesi C, Chiesa R, Coppi G, Brunkwall JS, Klarenbeek G, Cebrian A, Torsello G. First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial. J Vasc Surg. 2013 Apr;57(4):906-14. doi: 10.1016/j.jvs.2012.09.079. Epub 2013 Jan 18. | |
| 21894137 | Background |
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Of the 78 subjects consented and assessed for eligibility, 18 subjects did not meet all study entrance criteria and were considered screen failure.
There were 60 subjects enrolled in this trial at 7 sites in Germany and Italy from March 19, 2010 to June 20, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | The INCRAFTâ„¢ AAA Stent-graft System | The Cordis INCRAFTâ„¢ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | The INCRAFTâ„¢ AAA Stent-graft System | The Cordis INCRAFTâ„¢ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents. |
| 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, 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 | Rate of Technical Success Through the One Month Follow up. | Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up. | All enrolled subjects | Posted | Count of Participants | Participants | From procedure to one month follow up |
|
From Day 1 through 5 years post-procedure
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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 | The INCRAFTâ„¢ AAA Stent-graft System | The Cordis INCRAFTâ„¢ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma / bleeding puncture site - major | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma/bleeding puncture site - minor | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandy Maschhaupt, Clinical Project Manager | Cordis Corp. | 847-887-5744 | brandy.maschhaupt@cardinalhealth.com |
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| 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 Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure. |
Incidence of Stent-graft Migration annually through 5 years post - procedure. Stent-graft Migration is defined as being compared to the 30 day baseline assessment. |
| Day 30 through year 5 post-procedure |
| The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure. | The cumulative percentage of participants with Major Adverse Events (MAE) at annually through 5 years post - procedure; i.e., the percentage of MAE at Year 1 includes all MAEs occurred during the first year, the percentage at Year 2 includes all MAEs during the first two years, and etc. The Major adverse events include death, stroke, Q wave myocardial infarction, and renal failure | From day 1 through year 5 post-procedure |
| The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure. | The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks | From day 1 through year 5 post-procedure |
| The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of stent-graft fracture at 30 days and annually through 5 years post - procedure. Stent-graft fracture is defined as stent skeleton fracture and barb separation | From day 1 through year 5 post-procedure |
| The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of Thrombosis at hospital discharge at 30 days and annually through 5 years post - procedure. | From day 1 through year 5 post-procedure |
| The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of Stent Graft Explant at hospital discharge at 30 days and annually through 5 years post - procedure. | From day 1 through year 5 post-procedure |
| The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure. | From day 1 through year 5 post-procedure |
| Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT ultra-low profile AAA stent-graft system. J Cardiovasc Surg (Torino). 2011 Oct;52(5):661-7. |
| 24356046 | Background | Coppi G, Njila M, Coppi G, Saitta G, Silingardi R, Pratesi C, Chiesa R, Scheinert D, Brunkwall JS, Torsello G. INCRAFT(R) Stent-Graft System: one-year outcome of the INNOVATION Trial. J Cardiovasc Surg (Torino). 2014 Feb;55(1):51-9. |
| 25053535 | Background | Torsello G, Scheinert D, Brunkwall JS, Chiesa R, Coppi G, Pratesi C. Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2015 Jan;61(1):1-8. doi: 10.1016/j.jvs.2014.06.007. Epub 2014 Jul 19. |
| 30591290 | Derived | Torsello G, Pratesi G, van der Meulen S, Ouriel K; INNOVATION trial collaborators. Aortoiliac remodeling and 5-year outcome of an ultralow-profile endograft. J Vasc Surg. 2019 Jun;69(6):1747-1757. doi: 10.1016/j.jvs.2018.09.059. Epub 2018 Dec 24. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body mass index | Mean | Standard Deviation | kg/m² |
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| Diabetes | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Primary | Rate of Primary Safety Endpoint Within 1 Month Post-procedure. | Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure. | The analysis population consists of subjects with complete core laboratory data at 1 month. | Posted | Count of Participants | Participants | One month follow-up |
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| Secondary | Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure. | Incidence of aneurysm enlargement annually through 5 years post - procedure. Aneurysm enlargement is defined as being compared to the 30 day baseline assessment. | All enrolled subjects. However at each annual assessment of aneurysm enlargement, the numbers of follow-up subjects are 53, 50, 45, 39, 38 at year 1 through 5 respectively. | Posted | Number | percentage of subjects with endpoint | Day 30 through year 5 post-procedure |
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| Secondary | Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure. | Incidence of Stent-graft Migration annually through 5 years post - procedure. Stent-graft Migration is defined as being compared to the 30 day baseline assessment. | All enrolled subjects. However at each annual assessment of Stent-graft Migration, the numbers of follow-up subjects are 53, 50, 44, 38, 37 at year 1 through 5 respectively. | Posted | Number | percentage of subjects with endpoint | Day 30 through year 5 post-procedure |
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| Secondary | The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure. | The cumulative percentage of participants with Major Adverse Events (MAE) at annually through 5 years post - procedure; i.e., the percentage of MAE at Year 1 includes all MAEs occurred during the first year, the percentage at Year 2 includes all MAEs during the first two years, and etc. The Major adverse events include death, stroke, Q wave myocardial infarction, and renal failure | All enrolled subjects. However at each annual assessment of major adverse events, the numbers of follow-up subjects are 56, 52, 55, 51 and 50 at year 1 through 5 respectively. | Posted | Number | The cumulative percentage of Participant | From day 1 through year 5 post-procedure |
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| Secondary | The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure. | The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks | All enrolled subjects. However at each annual assessment of endoleaks, the numbers of follow-up subjects are 53, 50, 45, 39, 38 at year 1 through 5 respectively. | Posted | Number | percentage of subjects with endpoint | From day 1 through year 5 post-procedure |
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| Secondary | The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of stent-graft fracture at 30 days and annually through 5 years post - procedure. Stent-graft fracture is defined as stent skeleton fracture and barb separation | All enrolled subjects. However at each assessment of stent-graft fracture , the numbers of follow-up subjects are 54, 52, 46, 43, 40, 39 at 30 days and at year 1 through 5 respectively. | Posted | Number | percentage of subjects with endpoint | From day 1 through year 5 post-procedure |
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| Secondary | The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of Thrombosis at hospital discharge at 30 days and annually through 5 years post - procedure. | All enrolled subjects. However at each assessment of thrombosis , the numbers of follow-up subjects are 58, 56, 52, 55, 51, 50 at 30 days and at year 1 through 5 respectively. | Posted | Number | percentage of subjects with endpoint | From day 1 through year 5 post-procedure |
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| Secondary | The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of Stent Graft Explant at hospital discharge at 30 days and annually through 5 years post - procedure. | All enrolled subjects. However at each assessment of thrombosis , the numbers of follow-up subjects are 58, 55, 52, 55, 51, 50 at 30 days and at year 1 through 5 respectively. | Posted | Number | percentage of subjects with endpoint | From day 1 through year 5 post-procedure |
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| Secondary | The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure. | The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure. | All enrolled subjects. However at each assessment of stent-graft fracture , the numbers of follow-up subjects are 58, 53, 45, 45, 41, 39 at 30 days and at year 1 through 5 respectively. | Posted | Number | percentage of subjects with endpoint | From day 1 through year 5 post-procedure |
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| 8 |
| 60 |
| 44 |
| 60 |
| Pleural effusion | Infections and infestations | Systematic Assessment |
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| strong lymphatic wound secretions without infection | Blood and lymphatic system disorders | Systematic Assessment |
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| Claudication | Vascular disorders | Systematic Assessment |
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| Dissection | Vascular disorders | Systematic Assessment |
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| Lymphocele right groin postoperatively | Surgical and medical procedures | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Myocardial infarction | Vascular disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pseudo aneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arrhythmia - Bradycardia | Cardiac disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Prosthesis leaks (endoleak I) | General disorders | Systematic Assessment |
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| Prosthesis leaks (endoleak IV) | General disorders | Systematic Assessment |
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| Prosthesis occlusion/ stenosis | Vascular disorders | Systematic Assessment |
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| Atherosclerosis | Vascular disorders | Systematic Assessment |
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| Perforation | Vascular disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Post-implant syndrome | General disorders | Systematic Assessment |
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| Arterial occlusion | Vascular disorders | Systematic Assessment |
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| Hematoma/bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| High creatinine level | Investigations | Systematic Assessment |
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| Endoleak, type undetermined | General disorders | Systematic Assessment |
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| Asymptomatic lymphocele | Blood and lymphatic system disorders | Systematic Assessment |
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| Stent misplacement | Investigations | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Small infarct right kidney | Renal and urinary disorders | Systematic Assessment |
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| Periprocedural red cells transfusion | Blood and lymphatic system disorders | Systematic Assessment |
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| D001018 |
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