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NCT05145478 · ClinicalTrials.gov registry record
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
A clinical trial of Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by Yale University.
- Recruiting
- Registry status
- 50
- Enrollment target
- 2
- Study locations
NCT05145478: Recruiting study of Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by Yale University.
NCT05145478 is a study of Peripheral Arterial Disease and Critical Limb Ischemia that is actively recruiting participants, run by Yale University. The registered enrollment target is 50 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05145478, a study of Peripheral Arterial Disease and Critical Limb Ischemia, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Shockwave Intravascular Lithotripsy (IVL)
Study Locations (2)
Connecticut
- Yale New Haven Health - New Haven
Rhode Island
- The Miriam Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2027-06-01 |
What NCT05145478 shows while recruiting
NCT05145478 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which Shockwave Intravascular Lithotripsy (IVL) is the first listed.
NCT05145478 reports a single indexed study location in Connecticut, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05145478 about?
NCT05145478 is a clinical study titled "CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions". 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 ena...
What is the current status of trial NCT05145478?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2021-12-01. Estimated completion is 2027-06-01.
What conditions does trial NCT05145478 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Critical Limb Ischemia, Claudication, Femoral Arterial Calcification.
What interventions are being tested in trial NCT05145478?
The interventions under investigation include: Shockwave Intravascular Lithotripsy (IVL) (DEVICE).
Who is sponsoring clinical trial NCT05145478?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05145478 being conducted?
This trial has 2 study locations across Connecticut, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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