Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Aortic Valve Stenosis Clinical Trial

— ILIT  

Official title:

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862558
• Other study ID #: 022-277
• Status: Recruiting
• Start date: March 30, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Description:

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent

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:

1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.

2. Subject who has contraindications to IVL

3. Subject who has contraindications or is not eligible for TAVR

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Baylor Scott and White Heart Hospital	Plano	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Shockwave Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (12)

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 Hear — View 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 — View 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 Transfe — View 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 — View 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. — View 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 S — View 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. — View 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 — View 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. eCollectio — View 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. — View 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 — View 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.2 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Applicable VARC-3 criteria at the time of peripheral intervention for bleeding, access site and access related complications.	To understand the efficacy of the treatment	At IVL procedure
Secondary	Major adverse events within 1 year	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.	1 year after IVL procedure