An observational study in Femoral Arterial Calcification, Peripheral Arterial Disease and Claudication, sponsored by Yale University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Yale University · Observational
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.
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.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 50 is below the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Compared within Chronic Limb-Threatening Ischemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Angiographic Inclusion Criteria
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with calcified common-femoral artery disease, who are eligible to receive IVL per the FDA indications.
Device: 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.
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.
Time frame: 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.
Time frame: Baseline and 6 months
Rate of Procedural Success
Procedural success defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB
Time frame: Immediately post procedure
Number of Patients Free from TLR
Freedom from clinically driven target lesion revascularization (TLR). Assessed at 30 days, 6 months and 12 months.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months and 12 months
Change in Health Status
Health status will be measured using the disease-specific Peripheral Artery Questionnaire (PAQ). PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
Time frame: Baseline, 30 days and 6 months
Started Dec 2021 (actual). Primary completion is estimated for Dec 2026, 60 months after the start.
Of 46 non-industry observational studies under Chronic Limb-Threatening Ischemia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 60. This study's planned 60 months is above that.
Counting every sponsor, half of 51 studies reached it within 34 months; a quarter within 22 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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