RECRUITING

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

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Conditions

Femoral Arterial CalcificationPeripheral Arterial DiseaseClaudicationCritical Limb IschemiaPeripheral Artery Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-01
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05145478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs
  2. * Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines
  3. * 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.
  4. * Target lesion that is located in a native, de novo common femoral artery
  5. * Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
  6. * Target lesion is ≥70% stenosis by investigator via visual estimate.
  7. * Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.
  8. * Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.
  9. * Patient has open profunda femoris artery for the target leg, defined as no stenosis \>50%.
  10. * 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.
  1. * 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.
  2. * Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
  3. * Cognitive impairment as documented in medical records
  4. * Not speaking English or Spanish
  5. * Currently a prisoner
  6. * Pregnancy or nursing
  7. * Estimated survival less than 12 months at the time of screening
  8. * Prior history of CFA endarterectomy

Contacts and Locations

Study Contact

Kim Smolderen, PhD
CONTACT
203-737-7673
kim.smolderen@yale.edu

Principal Investigator

Carlos Mena-Hurtado, MD
PRINCIPAL_INVESTIGATOR
Yale University
Kim Smolderen, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Health
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Carlos Mena-Hurtado, MD, PRINCIPAL_INVESTIGATOR, Yale University
  • Kim Smolderen, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • Peripheral Artery Disease

Additional Relevant MeSH Terms

  • Femoral Arterial Calcification
  • Peripheral Arterial Disease
  • Claudication
  • Critical Limb Ischemia