Recruiting

Shockwave IVL

Sponsor:

Yale University

Code:

NCT05145478

Conditions

Femoral Arterial Calcification

Peripheral Arterial Disease

Claudication

Critical Limb Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shockwave Intravascular Lithotripsy (IVL)

Study Details

Brief summary:

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

Conditions

Femoral Arterial Calcification

Peripheral Arterial Disease

Claudication

Critical Limb Ischemia

Study ID

NCT05145478

Start date

Dec 1, 2021

Status verified date

Aug, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs
  • Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines
  • Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.

Angiographic Inclusion Criteria

  • Target lesion that is located in a native, de novo common femoral artery
  • Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
  • Target lesion is ≥70% stenosis by investigator via visual estimate.
  • Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.
  • Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.
  • Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

Exclusion Criteria:

  • Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
  • Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
  • Cognitive impairment as documented in medical records
  • Not speaking English or Spanish
  • Currently a prisoner
  • Pregnancy or nursing
  • Estimated survival less than 12 months at the time of screening
  • Prior history of CFA endarterectomy

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Shockwave Intravascular Lithotripsy (IVL)

Patients with calcified common-femoral artery disease, who are eligible to receive IVL per the FDA indications.

Interventions

Shockwave Intravascular Lithotripsy (IVL)

Eligible patients with atherosclerotic lesions in the femoral artery who either have claudication or critical limb ischemia will receive endovascular treatment in addition to be treated with Shockwave Intravascular Lithotripsy (IVL) technology.

Primary outcome measure

  • Change in Generic Health Status [ Time Frame: Baseline and 30 days ]
  • Change in Generic Health Status [ Time Frame: Baseline and 6 months ]
  • Rate of Procedural Success [ Time Frame: Immediately post procedure ]

Central Contacts and Locations

Central contacts

Kim Smolderen, PhD

203-737-7673kim.smolderen@yale.edu

Locations

Yale New Haven Health

Recruiting

New Haven, Connecticut, United States, 06510

More Information

Sponsor

Yale University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Peripheral Artery Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-14.