Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04484220
Status:
COMPLETED
Last Update Posted:
2025-04-16
First Post:
2020-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Patency Through 12 months Post-AVF Creation', 'timeFrame': '12 months post-procedure', 'description': 'Freedom from access abandonment from time of access creation'}, {'measure': 'Early Occlusion Rate at 7 days', 'timeFrame': '7 days post-procedure', 'description': 'Percent of patients with total occlusion within 7 days of the AVF creation procedure'}, {'measure': 'Study Related Serious Adverse Event (SAE) Rate Through 12 months', 'timeFrame': '12 months post-procedure', 'description': 'Rate of serious adverse events through 12 months related to the device, study procedure, or secondary procedure to maintain or re-establish patency.'}], 'secondaryOutcomes': [{'measure': 'Primary Patency Through 12 months Post-AVF Creation', 'timeFrame': '12 months post-procedure', 'description': 'Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months'}, {'measure': 'Assisted Primary Patency Through 12 months Post-AVF Creation', 'timeFrame': '12 months post-procedure', 'description': 'Freedom from access thrombosis from time of access creation'}, {'measure': 'Secondary Procedures Rate', 'timeFrame': '12 months post-procedure', 'description': 'Number of surgical or percutaneous interventions designed to mature or maintain the AVF or re-establish flow per person-year.'}, {'measure': 'Overall Patient Safety', 'timeFrame': '12 months post-procedure', 'description': 'A full characterization of adverse events during the study'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Renal Disease, End Stage', 'Kidney Disease, End-Stage', 'AV Fistula', 'Fistulas Arteriovenous']}, 'descriptionModule': {'briefSummary': 'The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.', 'detailedDescription': 'The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age\n2. Life expectancy of at least one year, in the investigator's opinion\n3. Diagnosed with ESRD or chronic kidney disease on hemodialysis.\n4. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment\n5. Adequate quality vein based on pre-operative assessment\n\n 1. Adjacent vein diameter of ≥2.0 mm at target anastomosis site\n 2. Confirmed clinically significant outflow\n6. Adequate quality radial artery based on pre-operative assessment\n\n a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site\n7. Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test.\n8. Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure\n9. Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution\n\n Imaging-based Inclusion Criteria:\n10. Confirm radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedurally\n11. Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site\n\nExclusion Criteria:\n\n1. Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including:\n\n 1. Documented or suspected central venous stenosis (≥ 50%) or\n 2. Upper extremity arterial stenosis or\n 3. Vascular disease at the radial artery / adjacent vein site\n2. Prior vascular surgery at or proximal (central) to the AVF target site interfering with AVF maturation or other ipsilateral surgery that could potentially confound the study results such as prior axillary dissection or mastectomy\n3. History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment\n4. Systolic pressures \\< 100 mg Hg at the time of screening\n5. Suspected or confirmed skin disease at the skin entry site\n6. Edema of the upper extremity on the ipsilateral side\n7. Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of \\> 10 mg per day\n8. Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment\n9. Patients with acute or active infection\n10. Scheduled kidney transplant within 6 months of enrollment\n11. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)\n12. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment\n13. Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19."}, 'identificationModule': {'nctId': 'NCT04484220', 'briefTitle': 'Ellipsys Vascular Access System Post Market Surveillance (PS) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004', 'orgStudyIdInfo': {'id': 'PS200001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ellipsys Vascular Access System', 'description': 'The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients who have chronic kidney disease requiring dialysis.', 'interventionNames': ['Device: Ellipsys Vascular Access System']}], 'interventions': [{'name': 'Ellipsys Vascular Access System', 'type': 'DEVICE', 'description': 'The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.', 'armGroupLabels': ['Ellipsys Vascular Access System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Nephrology Associates Access Center', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32218', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Azura Vascular Care, Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Vascular and Interventional, PLLC', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '022601', 'city': 'Hyannis', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'The Vascular Care Group', 'geoPoint': {'lat': 41.65289, 'lon': -70.2828}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nephrology Kidney Disease Hypertension Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburg Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'STAR Vascular Access Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78216', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Kidney Disease Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23236', 'city': 'North Chesterfield', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond Vascular Center', 'geoPoint': {'lat': 37.38, 'lon': -77.59}}], 'overallOfficials': [{'name': 'Haimanot Wasse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}