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Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nellix® System | Device | Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Major Adverse Events (MAE) | The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc | 30 days |
| Effectiveness: Rate of Treatment Success | The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows: It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; > 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Conversions, Death and Ruptures | Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023, | 2 Years |
| Device Integrity | Device Integrity is defined as the absence of device fracture, stenosis, kink, occlusion, or migration >5mm. All incidences of stent occlusion (100% device lumen obstruction) are also captured as stent stenosis (<100% device lumen obstruction). |
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INCLUSION CRITERIA
A patient who meets all of the following criteria potentially may be included in the study:
Male or female at least 18 years old;
Informed consent form understood and signed
Patient agrees to all follow-up visits;
Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
Anatomically eligible for the Nellix System (per Instructions For Use):
EXCLUSION CRITERIA
A patient who meets none of the following criteria potentially may be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Carpenter, MD | Cooper Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Vascular Consultants | Huntsville | Alabama | 35801 | United States | ||
| Regents of the University of California (UCLA) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Nellix EndoVascular Aneurysm Sealing System | Nellix EndoVascular Aneurysm Sealing System: The study is designed to evaluate the safety, effectiveness and performance of the Nellix System for endovascular aneurysm repair. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year, two year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 1 Month Follow-Up |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2020 |
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Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
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| 2 Years |
| Device Performance - Endoleak | Demonstrates device performance as indicated by the incidence of Endoleaks through study follow-up. Endoleak is determined by the CoreLab based on imaging completed. Endoleak is defined as clear evidence of contrast outside of one or both EndoBags which communicates with the aneurysm sac originating proximally at the infrarenal segment (Type IA), distally (Type IB); between components, if an extender is used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type II: e.g., lumbar artery; inferior mesenteric artery). | 2 Years |
| DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size | Average Sac Diameter size at Visit | 2 years |
| DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month | Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit | 2 Years |
| Secondary Interventions | All Secondary interventions reported during the study | 2 Years |
| LABS-RENAL FUNCTION (EGFR) | The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit | 2 Years |
| LABS- RENAL FUNCTION (CREATININE) | Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit | 2 Years |
| Los Angeles |
| California |
| 90095 |
| United States |
| Veterans Medical Research Foundation | San Diego | California | 92161 | United States |
| UC Health-Memorial Hospital | Colorado Springs | Colorado | 80909 | United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Miami Cardiac & Vascular Institute (MCVI) | Miami | Florida | 33176 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Coastal Vascular & Interventional | Pensacola | Florida | 32503 | United States |
| Christie Clinic | Champaign | Illinois | 61820 | United States |
| AMITA Health | Elk Grove Village | Illinois | 60007 | United States |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| McLaren Bay Region | Bay City | Michigan | 48708 | United States |
| Midwest Aortic & Vascular Institute | Kansas City | Missouri | 64116 | United States |
| The Cooper Health System | Camden | New Jersey | 08103 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Northeast Ohio Vascular Assoc (NEOVA) | Willoughby | Ohio | 44095 | United States |
| OU College of Medicine | Tulsa | Oklahoma | 74135 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97213 | United States |
| Palmetto Health- University of South Carolina | Columbia | South Carolina | 29203 | United States |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| Cardiovascular Surgery Clinic | Memphis | Tennessee | 38120 | United States |
| Inova Research Center | Falls Church | Virginia | 22042 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| Aspirus Research Institute | Wausau | Wisconsin | 54401 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| 6 Month Follow-Up |
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| 1 Year Follow-Up |
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| 2 Year Follow-Up |
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The baseline analysis population is 97 subjects. A total of 98 subjects were enrolled, with 97/98 subjects implanted with the Nellix System.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Nellix EndoVascular Aneurysm Sealing System | All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. The study is designed to evaluate the safety, effectiveness and performance of the Nellix System for endovascular aneurysm repair. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year, two years (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment). |
| 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 |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| ASA Class (ASA Physical Status Classification System) | ASA 1: A normal healthy patient. No systemic disease. ASA 2: A patient with mild systemic disease. No significant impact on daily activity. ASA 3: A patient with severe systemic disease that limits activity but is not incapacitating. Significant impact on daily activity. ASA 4: A patient with severe systemic disease that is a constant threat to life. Life threatening conditions or multiple serious health issues. ASA 5: A moribund patient who is not expected to survive without the operation. Surgery is a last-ditch effort to save life. | Count of Participants | Participants |
| ||||||||||||||||||||||
| SVS Class (Society for Vascular Surgery Classification System) SVS/AAVS comorbidity score | The overall SVS/AAVS comorbidity score is the sum of grades for the three organ systems (cardiac status, pulmonary status, and renal function): Low risk: Total score 0-3. Moderate risk: Total score 4-6. High risk: Total score 7-9. | Count of Participants | Participants |
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| 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 | Safety: Major Adverse Events (MAE) | The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc | 98 patients enrolled under the study | Posted | Number | Number of Events | 30 days |
|
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| Primary | Effectiveness: Rate of Treatment Success | The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows: It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; > 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect. | Only 77 subjects completed study related procedures at 2 year time point. | Posted | Number | percentage of treatment success | 2 year |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Conversions, Death and Ruptures | Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023, | 93 subjects that completed their 2 year visit as of the data cut off of 07Jul2023 | Posted | Number | Number of Events | 2 Years |
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| Secondary | Device Integrity | Device Integrity is defined as the absence of device fracture, stenosis, kink, occlusion, or migration >5mm. All incidences of stent occlusion (100% device lumen obstruction) are also captured as stent stenosis (<100% device lumen obstruction). | 75 participants that were analyzed for device integrity as of 07Jul2023, Data for >5mm Migration includes subjects with Migration >10mm as well. | Posted | Number | Number of Events | 2 Years |
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| Secondary | Device Performance - Endoleak | Demonstrates device performance as indicated by the incidence of Endoleaks through study follow-up. Endoleak is determined by the CoreLab based on imaging completed. Endoleak is defined as clear evidence of contrast outside of one or both EndoBags which communicates with the aneurysm sac originating proximally at the infrarenal segment (Type IA), distally (Type IB); between components, if an extender is used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type II: e.g., lumbar artery; inferior mesenteric artery). | 75 subjects analyzed for Endoleaks at 2 years as of the data cut-off date of 07Jul2023 | Posted | Count of Participants | Participants | No | 2 Years |
|
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| Secondary | DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size | Average Sac Diameter size at Visit | 76 Subjects that were analyzed at 2 years for Average Sac size in diameters as of the data cut-off date of 07Jul2023 | Posted | Mean | Standard Deviation | mm | 2 years |
|
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| Secondary | DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month | Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit | 76 Subjects that were analyzed at 2 years for changes in Diameter sac Changes since 1month as of the cutoff date of 07Jul2023 | Posted | Number | Number of subjects | 2 Years |
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| Secondary | Secondary Interventions | All Secondary interventions reported during the study | 93 subjects analyzed for the number of secondary interventions | Posted | Number | Number of Events | 2 Years |
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| Secondary | LABS-RENAL FUNCTION (EGFR) | The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit | 80 subjects analyzed for renal function (eGFR) at 2 years as of the data cut-off date of 07Jul2023 | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | 2 Years |
|
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| Secondary | LABS- RENAL FUNCTION (CREATININE) | Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit | 80 subjects analyzed for renal function (Creatinine) at 2 years as of the data cut-off date of 07Jul2023 | Posted | Mean | Standard Deviation | mg/dL | 2 Years |
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All Adverse Events data occurring during the study period were collected (i.e. procedure through 5 years follow-up). The data reported here are as of the data cut for 2-year primary endpoint data.
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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 | Single Arm Nellix EndoVascular Aneurysm Sealing System | Nellix EndoVascular Aneurysm Sealing System: The study is designed to evaluate the safety, effectiveness and performance of the Nellix System for endovascular aneurysm repair. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year, two year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment). | 7 | 98 | 49 | 98 | 22 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Bowel | Gastrointestinal disorders | Systematic Assessment |
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| Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Chimney Device | Surgical and medical procedures | Systematic Assessment |
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| Malignancies | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Miscellaneous | General disorders | Systematic Assessment |
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| Nellix Device | Product Issues | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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| Surgical Site Wound | Surgical and medical procedures | Systematic Assessment |
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| Urogenital | Renal and urinary disorders | Systematic Assessment |
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| Vascular | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Bowel | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Nellix Device | Product Issues | Systematic Assessment |
| ||
| Malignancies | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Miscellaneous | General disorders | Systematic Assessment |
| ||
| Chimney Device | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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| Surgical Site Wound | Surgical and medical procedures | Systematic Assessment |
| ||
| Urogenital | Renal and urinary disorders | Systematic Assessment |
| ||
| Vascular | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy Stiver, Manager, Clinical Affairs | Endologix LLC | +15136731452 | tstiver@endologix.com |
| Jul 15, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2020 | Jul 15, 2024 | ICF_001.pdf |
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| Title | Measurements |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Conversion to open repair due to aneurysm expansion |
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| Iliac Extension due to aneurysm expansion |
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| Iliac Stenting due to renal failure |
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| Renal stent due to renal failure |
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| Iliac Extension due to Vessel Dissection (Non aortic) |
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| Thrombolysis due to Vessel Dissection (Non aortic) |
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| Conversion to Open Repair due to endoleak IA |
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| Coil Embolization due to Endoleak II |
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| Thrombolysis due to Stent Thrombosis |
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| Stent relining due to Stent Thrombosis |
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| Fem-Fem Bypass due to Stent Thrombosis |
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| Conversion to Open Repair due to stent migration |
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| Renal stent due to Renal Artery Occlusion |
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