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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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

Treatments Being Tested

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.

Locations (2)

Yale New Haven Health
New Haven, Connecticut, United States
The Miriam Hospital
Providence, Rhode Island, United States