Recruiting

Intravascular Lithotripsy

Sponsor:

Baylor Research Institute

Code:

NCT05862558

Conditions

Iliac Disease

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Shockwave Balloon

Study Details

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

Study ID

NCT05862558

Start date

Mar 30, 2023

Status verified date

Aug, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Acute technical success per the DISRUPT PAD definition at the time of intervention [ Time Frame: At time of IVL procedure ]
  • Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment [ Time Frame: At the time of TAVR procedure ]

Central Contacts and Locations

Locations

Baylor Scott and White Heart Hospital

Recruiting

Plano, Texas, United States, 75093

Contacts

Denise Espinoza

4698144783denise.espinoza@bswhealth.org

Sarah Hale

4698144845sarah.hale@bswhealth.org

Principal Investigator:

Karim Al-Azizi, MD

More Information

Sponsor

Baylor Research Institute

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-08-21.