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.
Study Type
OBSERVATIONAL
Enrollment
50
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.
Yale New Haven Health
New Haven, Connecticut, United States
RECRUITINGThe Miriam Hospital
Providence, Rhode Island, United States
NOT_YET_RECRUITINGChange 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
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