Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT06029660
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2023-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094682', 'term': 'Endovascular Aneurysm Repair'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019917', 'term': 'Blood Vessel Prosthesis Implantation'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Subjects will be blinded to the treatment arm prior to the index procedure; after the procedure, they will be unblinded prior to discharge to prevent unintentional unblinding due to imaging'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, multicenter, randomized, open-label trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-09-01', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Endpoint : AAA Sac Regression at 1 year', 'timeFrame': '1 year', 'description': 'The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.'}, {'measure': 'Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days', 'timeFrame': '30 days', 'description': 'Freedom from the following through 30 days post-index procedure:\n\n* Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss \\>1000 mL.\n* AAA-rupture or AAA-perforation\n* Conversion to Open Repair'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Abdominal Aortic Aneurysm'], 'conditions': ['Aortic Aneurysm, Abdominal']}, 'descriptionModule': {'briefSummary': 'To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥18 years of age\n2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;\n3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \\<50%, based on pre-procedure CTA\n4. Maximum Lumen diameter within the AAA sac of ≥40mm.\n5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.\n\nExclusion Criteria:\n\nGeneral\n\n1. An inability to provide informed consent.\n2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.\n3. Unable or unwilling to comply with study follow-up requirements.\n4. Prisoner or member of other vulnerable population\n\nAnatomical\n\n1. Concomitant iliac artery ectasia or aneurysm\n2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.\n3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.\n4. Connective tissue disorder (e.g., Marfan's syndrome)\n5. Aneurysmal disease of the descending thoracic aorta\n6. Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties\n\nEVAR/Procedural\n\n1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA\n2. Use of an aortic stent graft other than those specified1 for a particular site\n3. Planned use of the chosen stent graft outside its instructions for use (IFU)\n4. Use of fenestrated stent grafts or chimney techniques\n5. Use of the Heli-FX EndoAnchor system\n6. Use of embolic devices other than the investigational product to embolize the AAA sac\n7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries\n8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries\n\nMedical History/Conditions\n\n1. Coagulopathy or uncontrolled bleeding disorder\n2. Serum creatinine level \\>2.5 mg/dL\n3. Cerebrovascular accident within 3 months prior to the procedure\n4. Myocardial infarction and/or major heart surgery within 3 months prior to the procedure\n5. Atrial fibrillation that is not well rate controlled\n6. Life expectancy of \\<2 years post-procedure\n7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.\n8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC \\>11,000/mm3)\n9. A condition that inhibits radiographic visualization during the implantation procedure\n10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.\n11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial\n12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial"}, 'identificationModule': {'nctId': 'NCT06029660', 'briefTitle': 'AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shape Memory Medical, Inc.'}, 'officialTitle': 'AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion', 'orgStudyIdInfo': {'id': 'CRD 1029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.', 'interventionNames': ['Device: IMPEDE-FX RapidFill Implants', 'Procedure: EndoVascular Aneurysm Repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control Arm: Subjects in the control arm will only have an EVAR device implanted.', 'interventionNames': ['Procedure: EndoVascular Aneurysm Repair']}], 'interventions': [{'name': 'IMPEDE-FX RapidFill Implants', 'type': 'DEVICE', 'description': 'Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants', 'armGroupLabels': ['Treatment']}, {'name': 'EndoVascular Aneurysm Repair', 'type': 'PROCEDURE', 'otherNames': ['EVAR'], 'description': 'Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.', 'armGroupLabels': ['Control', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca St. John', 'role': 'CONTACT', 'email': 'rstjohn@uabmc.edu'}, {'name': 'Deborah Weber', 'role': 'CONTACT', 'email': 'dlowe@uabmc.edu'}, {'name': 'Adam Beck, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kiersten Rundio', 'role': 'CONTACT', 'email': 'krundio@honorhealth.com'}, {'name': 'Amanda Xu', 'role': 'CONTACT', 'email': 'amxu@honorhealth.com'}, {'name': 'Venkatesh Ramaiah, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stephanie Wilson, N.P.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hasan Aldailami, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Honor Health', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Varela', 'role': 'CONTACT', 'email': 'Stephanie.Varela@med.usc.edu'}, {'name': 'Han Sukgu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'USC Keck', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annalicia Vargas', 'role': 'CONTACT', 'email': 'annalicia.vargas@va.gov', 'phone': '858-642-1477'}, {'name': 'Ann Gaffey, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Diego VA Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordan Sprechman', 'role': 'CONTACT', 'email': 'jordan.sprechman@tenethealth.com'}, {'name': 'Paola Ramirez', 'role': 'CONTACT', 'email': 'paola1.ramirez@tenethealth.com'}, {'name': 'Joseph Ricotta, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Delray Medical Center', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Ngo', 'role': 'CONTACT', 'email': 'george.ngo@orlandohealth.com', 'phone': '(321) 843-9657'}, {'name': 'Aleem Mirza, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gino Casteneda, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Johnson', 'role': 'CONTACT', 'email': 'eej11@usf.edu'}, {'name': 'Konstantinos Arnaoutakis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shaneka Douglas', 'role': 'CONTACT', 'email': 'shaneka.douglas@emoryhealthcare.org'}, {'name': 'Yazan Duwayri, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'James Chang, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mackenton Johnson', 'role': 'CONTACT', 'email': 'mackenton.johnson@bsd.uchicago.edu', 'phone': '773-795-3639'}, {'name': 'Trissa Babrowski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimmy Marshall', 'role': 'CONTACT', 'email': 'marshki@iu.edu'}, {'name': 'Raghu Motaganahalli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gregory Westin, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andres Fajardo, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Indiana 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'nkotturu@bwh.harvard.edu', 'phone': '617-525-8555'}, {'name': 'Nicholas Swerdlow, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamad Hussain, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Omar Selim, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jorge Gomez-Mayorga', 'role': 'CONTACT', 'email': 'jgomezma@bidmc.harvard.edu'}, {'name': 'Marc Schermerhorn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Allen Hamdan, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lars Stangenberg, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mark Wyers, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patric Liang, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Belanger', 'role': 'CONTACT', 'email': 'karen.belanger@va.gov'}, {'name': 'Nicholas Osborne, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Ann Arbor Healthcare', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Crystal Coulter-Robinson', 'role': 'CONTACT', 'email': 'Crystal.Coulter-Robinson@corewellhealth.org'}, {'name': 'Eanas S. Yassa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Justin Simmons, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrew Kimball, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Corewell Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Haen', 'role': 'CONTACT', 'email': 'haen.jennifer@mayo.edu'}, {'name': 'Randall DeMartino, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Keyes', 'role': 'CONTACT', 'email': 'michelle.r.keyes@hitchcock.org'}, {'name': 'Bjoern Suckow, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jocelyn Beach', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthew Alef, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jesse Columbo, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rebecca Scully, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer Stableford, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robin Stein', 'role': 'CONTACT', 'email': 'rmstein3@buffalo.edu'}, {'name': 'Linda Harris, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Galla', 'role': 'CONTACT', 'email': 'ann.galla@va.gov'}, {'name': 'Hasan Dosluoglu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mariel Rivero, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Buffalo VA Western New York', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gina Bernardez', 'role': 'CONTACT', 'email': 'Gina.Bernardez@nyulangone.org'}, {'name': 'Thomas Maldonado, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claudia Musat', 'role': 'CONTACT', 'email': 'cm2065@cumc.columbia.edu', 'phone': '212-342-4102'}, {'name': 'Virendra Patel, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Danielle Bajakian, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Edvard Skripochnik, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicholas Morrissey, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Columbia University Irving Medical Center/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Bourret', 'role': 'CONTACT', 'email': 'mary_bourret@urmc.rochester.edu'}, {'name': 'Grayson Pitcher, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Stoner, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daria Shavarina', 'role': 'CONTACT', 'email': 'daria.shavarina@stonybrookmedicine.edu'}, {'name': 'Apostolos Tassiopoulos, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Angela Kokkosis, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stony Brook Medicine', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adeteju Mowo-Wale', 'role': 'CONTACT', 'email': 'Adeteju_Mowo-Wale@trihealth.com'}, {'name': 'Patrick Muck, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthew Recht, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mark Broering, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adam Reichard, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'TriHealth Heart Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Subhashish Das', 'role': 'CONTACT', 'email': 'subhashish.das@osumc.edu', 'phone': '614-366-6596'}, {'name': 'Kristine Orion, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bryan Tillman, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kyongjune Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiaoyi Teng, M.D.', 'role': 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