CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

NCT05145478 | Recruiting FDA Device

• 1 other identifier: 2000031113
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (3)

• Change in Generic Health Status

  Generic Health Status will be measured using the EQ5D health status assessment. Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Higher scores indicate more severe or frequent problems.

  Baseline and 30 days

• Change in Generic Health Status

  Generic Health Status will be measured using the EQ5D health status assessment. Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Higher scores indicate more severe or frequent problems.

  Baseline and 6 months

• Rate of Procedural Success

  Procedural success defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB

  Immediately post procedure

Secondary Outcomes (5)

• Number of Patients Free from TLR

  Up to 12 months

• Number of patients with new-onset MAEs

  Up to 12 months

• Rate of Periprocedural clinical success

  During admission, before discharge up to 48 hours

• Change in Clinical Success

  Baseline and 30 days

• Change in Clinical Success

  Baseline, 6 months and 12 months

Other Outcomes (1)

• Change in Health Status

  Baseline, 30 days and 6 months

Study Arms (1)

Shockwave Intravascular Lithotripsy (IVL)

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

Device: Shockwave Intravascular Lithotripsy (IVL)

Interventions

Shockwave Intravascular Lithotripsy (IVL) DEVICE

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.

Shockwave Intravascular Lithotripsy (IVL)

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Shockwave Medical, Inc.: collaborator
• Brown University: collaborator

Study Sites (2)

Yale New Haven Health

New Haven, Connecticut, 06510, United States

RECRUITING

The Miriam Hospital

Providence, Rhode Island, 02906, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Officials

• Carlos Mena-Hurtado, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Kim Smolderen, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Smolderen, PhD

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 6, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (2)