Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT05862558
Status:
RECRUITING
Last Update Posted:
2023-05-17
First Post:
2023-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute technical success per the DISRUPT PAD definition at the time of intervention', 'timeFrame': 'At time of IVL procedure', 'description': 'Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion'}, {'measure': 'Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment', 'timeFrame': 'At the time of TAVR procedure', 'description': 'To know the efficacy of the treatment'}], 'secondaryOutcomes': [{'measure': 'Applicable VARC-3 criteria at the time of peripheral intervention for bleeding, access site and access related complications.', 'timeFrame': 'At IVL procedure', 'description': 'To understand the efficacy of the treatment'}, {'measure': 'Major adverse events within 1 year', 'timeFrame': '1 year after IVL procedure', 'description': 'need for emergency surgical revascularization of target limb, unplanned target limb major amputation (above the ankle), symptomatic thrombus or distal emboli that requires surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization, perforations that require an intervention, including bail-out stenting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iliac Disease', 'Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '32387164', 'type': 'RESULT', 'citation': 'Junquera L, Kalavrouziotis D, Cote M, Dumont E, Paradis JM, DeLarochelliere R, Rodes-Cabau J, Mohammadi S. Results of transcarotid compared with transfemoral transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2022 Jan;163(1):69-77. doi: 10.1016/j.jtcvs.2020.03.091. Epub 2020 Apr 13.'}, {'pmid': '27040324', 'type': 'RESULT', 'citation': 'Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.'}, {'pmid': '31758362', 'type': 'RESULT', 'citation': 'Ristalli F, Dini CS, Stolcova M, Nardi G, Valente S, Meucci F, Di Mario C. Role of Lithotripsy for Small Calcified Iliacs in the Era of Big Devices. Curr Cardiol Rep. 2019 Nov 22;21(11):143. doi: 10.1007/s11886-019-1245-2.'}, {'pmid': '30190074', 'type': 'RESULT', 'citation': 'Kumar N, Khera R, Fonarow GC, Bhatt DL. Comparison of Outcomes of Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Implantation. Am J Cardiol. 2018 Nov 1;122(9):1520-1526. doi: 10.1016/j.amjcard.2018.07.025. Epub 2018 Aug 7.'}, {'pmid': '29425605', 'type': 'RESULT', 'citation': 'Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Munoz DR, Rosenhek R, Sjogren J, Mas PT, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL. 2017 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Rev Esp Cardiol (Engl Ed). 2018 Feb;71(2):110. doi: 10.1016/j.rec.2017.12.013. No abstract available. English, Spanish.'}, {'pmid': '30019839', 'type': 'RESULT', 'citation': 'Rogers T, Gai J, Torguson R, Okubagzi PG, Shults C, Ben-Dor I, Satler LF, Waksman R. Predicted magnitude of alternate access in the contemporary transcatheter aortic valve replacement era. Catheter Cardiovasc Interv. 2018 Nov 1;92(5):964-971. doi: 10.1002/ccd.27668. Epub 2018 Jul 18.'}, {'pmid': '30846091', 'type': 'RESULT', 'citation': 'Di Mario C, Goodwin M, Ristalli F, Ravani M, Meucci F, Stolcova M, Sardella G, Salvi N, Bedogni F, Berti S, Babaliaros VC, Pop A, Caparrelli D, Stewart J, Devireddy C. A Prospective Registry of Intravascular Lithotripsy-Enabled Vascular Access for Transfemoral Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Mar 11;12(5):502-504. doi: 10.1016/j.jcin.2019.01.211. No abstract available.'}, {'pmid': '32567327', 'type': 'RESULT', 'citation': 'Kassimis G, Didagelos M, De Maria GL, Kontogiannis N, Karamasis GV, Katsikis A, Sularz A, Karvounis H, Kanonidis I, Krokidis M, Ziakas A, Banning AP. Shockwave Intravascular Lithotripsy for the Treatment of Severe Vascular Calcification. Angiology. 2020 Sep;71(8):677-688. doi: 10.1177/0003319720932455. Epub 2020 Jun 22.'}, {'pmid': '30772295', 'type': 'RESULT', 'citation': 'Cruz-Gonzalez I, Gonzalez Ferreiro R, Martin Moreiras J, Trejo Velasco B, Barreiro Perez M, Diego Nieto A, Herrero Garibi J, Rodriguez Collado J, Sanchez Fernandez PL. Facilitated Transfemoral Access by Shockwave Lithoplasty for Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Mar 11;12(5):e35-e38. doi: 10.1016/j.jcin.2018.11.041. Epub 2019 Feb 13. No abstract available.'}, {'pmid': '30196575', 'type': 'RESULT', 'citation': 'Gorla R, Cannone GS, Bedogni F, De Marco F. Transfemoral aortic valve implantation following lithoplasty of iliac artery in a patient with poor vascular access. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):E140-E142. doi: 10.1002/ccd.27812. Epub 2018 Sep 9.'}, {'pmid': '34631837', 'type': 'RESULT', 'citation': 'Sawaya FJ, Bajoras V, Vanhaverbeke M, Wang C, Bieliauskas G, Sondergaard L, De Backer O. Intravascular Lithotripsy-Assisted Transfemoral TAVI: The Copenhagen Experience and Literature Review. Front Cardiovasc Med. 2021 Sep 22;8:739750. doi: 10.3389/fcvm.2021.739750. eCollection 2021.'}, {'pmid': '33748555', 'type': 'RESULT', 'citation': 'Price LZ, Safir SR, Faries PL, McKinsey JF, Tang GHL, Tadros RO. Shockwave lithotripsy facilitates large-bore vascular access through calcified arteries. J Vasc Surg Cases Innov Tech. 2020 Sep 12;7(1):164-170. doi: 10.1016/j.jvscit.2020.09.002. eCollection 2021 Mar.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)', 'detailedDescription': 'The goal of this post-market, prospective, observational single-arm cohort study is to assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid). This is a study of patients referred to BSW The Heart Hospital, Plano for evaluation of critical aortic stenosis. Those planned to undergo TAVR, have prohibitive iliofemoral disease, and otherwise considered for alternative access, will be considered for the study. The medical devices being used are in the post-market stage as it is being used in accordance with its approved labeling, treating iliofemoral disease.\n\nStudy data will be recorded prospectively on dedicated Data Collection Forms and stored locally in a secure format. De-identified data will be uploaded for statistical analysis. IRB approval for the study will be obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects must meet the inclusion criteria and have none of the exclusion criteria to be eligible for participation in this study.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent\n2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).\n3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure\n4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.\n5. Subjects can provide written, informed consent.\n\nExclusion Criteria:\n\n1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.\n2. Subject who has contraindications to IVL\n3. Subject who has contraindications or is not eligible for TAVR"}, 'identificationModule': {'nctId': 'NCT05862558', 'acronym': 'ILIT', 'briefTitle': 'Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR', 'orgStudyIdInfo': {'id': '022-277'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Shockwave Balloon', 'type': 'DEVICE', 'description': 'Intravascular lithotripsy (IVL) performed with the Shockwave balloon (Shockwave Medical Inc) enables treatment of calcified stenosis of the peripheral arteries by using sonic pressure waves to selectively disrupt superficial and deep calcium without impacting healthy tissue'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Denise Espinoza', 'role': 'CONTACT', 'email': 'denise.espinoza@bswhealth.org', 'phone': '469-814-4783'}, {'name': 'Sarah Hale', 'role': 'CONTACT', 'email': 'sarah.hale@bswhealth.org', 'phone': '4698144845'}, {'name': 'Karim Al-Azizi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor Scott and White Heart Hospital', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}