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

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ClinicalTrials.gov Identifier: NCT05145478
Recruitment Status : Recruiting
First Posted : December 6, 2021
Last Update Posted : February 3, 2022
Sponsor:
Collaborators:
Shockwave Medical, Inc.
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Yale University

Brief 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 of comparative effectiveness research.

Condition or disease Intervention/treatment
Femoral Arterial Calcification Peripheral Arterial Disease Claudication Critical Limb Ischemia Device: Shockwave Intravascular Lithotripsy (IVL)

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Shockwave Intravascular Lithotripsy (IVL)
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.




Primary Outcome Measures :
  1. Change in Generic Health Status [ Time Frame: Baseline and 30 days ]
    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.

  2. Change in Generic Health Status [ Time Frame: Baseline and 6 months ]
    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.

  3. Rate of Procedural Success [ Time Frame: Immediately post procedure ]
    Procedural success defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB


Secondary Outcome Measures :
  1. Number of Patients Free from TLR [ Time Frame: Up to 12 months ]
    Freedom from clinically driven target lesion revascularization (TLR). Assessed at 30 days, 6 months and 12 months.

  2. Number of patients with new-onset MAEs [ Time Frame: Up to 12 months ]

    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

  3. Rate of Periprocedural clinical success [ Time Frame: During admission, before discharge up to 48 hours ]
    Periprocedural clinical success as defined by residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting.

  4. Change in Clinical Success [ Time Frame: Baseline and 30 days ]
    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.

  5. Change in Clinical Success [ Time Frame: Baseline, 6 months and 12 months ]
    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.


Other Outcome Measures:
  1. Change in Health Status [ Time Frame: Baseline, 30 days and 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.
  • Patient has open profunda femoris artery for the target leg, defined as no stenosis >50%.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05145478


Contacts
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Contact: Kim Smolderen, PhD 203-737-7673 kim.smolderen@yale.edu
Contact: Carla Castro, MS 203-737-1168 carla.castro@yale.edu

Locations
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United States, Connecticut
Yale New Haven Health Recruiting
New Haven, Connecticut, United States, 06510
Contact: Carlos Mena-Hurtado, MD         
Sponsors and Collaborators
Yale University
Shockwave Medical, Inc.
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Carlos Mena-Hurtado, MD Yale University
Principal Investigator: Kim Smolderen, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT05145478    
Other Study ID Numbers: 2000031113
First Posted: December 6, 2021    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Yale University:
Peripheral Artery Disease
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases