Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
NCT ID: NCT05862558
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-03-30
2026-06-01
Brief Summary
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Detailed Description
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Study 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Shockwave Balloon
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
Eligibility Criteria
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Inclusion Criteria
2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
5. Subjects can provide written, informed consent.
Exclusion Criteria
2. Subject who has contraindications to IVL
3. Subject who has contraindications or is not eligible for TAVR
18 Years
90 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Baylor Research Institute
OTHER
Responsible Party
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Locations
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Baylor Scott and White Heart Hospital
Plano, Texas, United States
Countries
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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022-277
Identifier Type: -
Identifier Source: org_study_id
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