Femoral Arterial CalcificationNCT05145478
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
An observational study of Femoral Arterial Calcification and Peripheral Arterial Disease, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication
- What is being tested?
- Shockwave Intravascular Lithotripsy (IVL)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2021to 1 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale New Haven Health
New Haven, Connecticut, 06510
Carlos Mena-Hurtado, MD
- Not yet recruiting
The Miriam Hospital
Providence, Rhode Island, 02906
Peter A Soukas, MD, 401-793-4105, psoukas@brownhealth.org
About this study
Official title: CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
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.
Read the detailed description
The primary objective of this study is to evaluate the generic health status outcomes and efficacy and safety outcomes following use of the Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with PAD seen in routine clinical practice.
The main testable hypothesis is that the use of IVL is associated with a health status improvement that is equal or higher than the threshold of a minimally clinically important difference on the EQ5D. Preliminarily data will be derived for the primary endpoint target lesion revascularization to enable future planning of larger comparative effectiveness research.
Secondary objectives of the study are to document procedural success following the use of IVL in common femoral lesions, disease stage change, as well as disease-specific health status in the real-world.
- Conditions
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Being tested
- Shockwave Intravascular Lithotripsy (IVL)
- Keywords
- Peripheral Artery Disease
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Shockwave Intravascular Lithotripsy (IVL) | Patients with calcified common-femoral artery disease, who are eligible to receive IVL per the FDA indications. Receives: Device: Shockwave Intravascular Lithotripsy (IVL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 months
Rate of Procedural Success
Procedural success defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB
Measured: Immediately post procedure
Secondary outcomes (5)
Number of Patients Free from TLR
Freedom from clinically driven target lesion revascularization (TLR). Assessed at 30 days, 6 months and 12 months.
Measured: Up to 12 months
Number of patients with new-onset MAEs
The composite of new-onset Major Adverse Events (MAEs) is comprised of:
- Need for emergency surgical revascularization of target limb, including CFA endarterectomy
- Unplanned target limb major amputation (above the ankle)
- Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization
- Perforations that require an intervention, including bail-out stenting
Measured: Up to 12 months
Rate of Periprocedural clinical success
Periprocedural clinical success as defined by residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting.
Measured: During admission, before discharge up to 48 hours
Change in Clinical Success
Rutherford Category. Classification of PAD into acute and chronic limb ischemia associated by clinical symptoms. Evaluates patient's chronic limb pain and claudication by ABI/TBI. The category scale is from 0-6. The clinical interpretation of the scale is that a higher category indicates a worse condition.
Measured: Baseline and 30 days
Change in Clinical Success
Rutherford Category. Classification of PAD into acute and chronic limb ischemia associated by clinical symptoms. Evaluates patient's chronic limb pain and claudication by ABI/TBI. The category scale is from 0-6. The clinical interpretation of the scale is that a higher category indicates a worse condition.
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Arterial CalcificationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Shockwave Medical, Inc., Brown University
- Responsible party
- Sponsor
- Investigators
- Carlos Mena-Hurtado, MD, Principal investigator, Yale UniversityKim Smolderen, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145478
- Sponsor's protocol ID
- 2000031113
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes