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| Name | Class |
|---|---|
| Shockwave Medical, Inc. | INDUSTRY |
| Brown University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwave Intravascular Lithotripsy (IVL) | Patients with calcified common-femoral artery disease, who are eligible to receive IVL per the FDA indications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Free from TLR | Freedom from clinically driven target lesion revascularization (TLR). Assessed at 30 days, 6 months and 12 months. | Up to 12 months |
| Number of patients with new-onset MAEs |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 30 days and 6 months |
Inclusion Criteria:
Angiographic Inclusion Criteria
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim Smolderen, PhD | Contact | 203-737-7673 | kim.smolderen@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Mena-Hurtado, MD | Yale University | Principal Investigator |
| Kim Smolderen, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Health | Recruiting | New Haven | Connecticut | 06510 | United States |
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The composite of new-onset Major Adverse Events (MAEs) is comprised of:
| 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. | 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. | 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. | Baseline, 6 months and 12 months |
| The Miriam Hospital | Not yet recruiting | Providence | Rhode Island | 02906 | United States |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D007511 | Ischemia |
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