Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

NCT05862558 | Recruiting

• 1 other identifier: 022-277
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Iliac Disease; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Acute technical success per the DISRUPT PAD definition at the time of intervention

  Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion

  At time of IVL procedure

• Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment

  To know the efficacy of the treatment

  At the time of TAVR procedure

Secondary Outcomes (2)

• Applicable VARC-3 criteria at the time of peripheral intervention for bleeding, access site and access related complications.

  At IVL procedure

• Major adverse events within 1 year

  1 year after IVL procedure

Interventions

Shockwave Balloon DEVICE

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

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects must meet the inclusion criteria and have none of the exclusion criteria to be eligible for participation in this study.

You may qualify if:

• Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
• Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
• Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
• Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
• Subjects can provide written, informed consent.

You may not qualify if:

• Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
• Subject who has contraindications to IVL
• Subject who has contraindications or is not eligible for TAVR

Sponsors & Collaborators

• Baylor Research Institute: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (1)

Baylor Scott and White Heart Hospital

Plano, Texas, 75093, United States

RECRUITING

Related Publications (12)

• 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: 32387164 RESULT

• 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: 27040324 RESULT

• 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: 31758362 RESULT

• 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: 30190074 RESULT

• 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: 29425605 RESULT

• 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: 30019839 RESULT

• 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: 30846091 RESULT

• 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: 32567327 RESULT

• 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: 30772295 RESULT

• 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: 30196575 RESULT

• 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: 34631837 RESULT

• 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.

  PMID: 33748555 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: March 30, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-10

Locations

US (1)