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NCT04241224 · ClinicalTrials.gov registry record · NA
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
A NA study of Peripheral Arterial Disease, sponsored by Ra Medical Systems.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 10
- Study locations
NCT04241224: Completed NA study of Peripheral Arterial Disease, sponsored by Ra Medical Systems.
NCT04241224 is a NA study of Peripheral Arterial Disease that has completed, run by Ra Medical Systems. The registered enrollment target is 108 participants, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04241224, a NA study of Peripheral Arterial Disease, has completed, sponsored by Ra Medical Systems.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 10
- Study locations
Study Summary
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
Primary Outcome
The Primary Efficacy Endpoint is the mean reduction in percent diameter stenosis in each subject's primary lesion following treatment with the DABRA Laser System and before any other treatment, as assessed by an independent Angiographic Core Laboratory.
Conditions Studied
Interventions
- DEVICE Atherectomy
Study Locations (10)
Texas
- South Texas Vascular Institute - Edinburg
- Texas Tech University Health Sciences Center - Center for Cardiovascular Health - Lubbock
- Laser Surgical Solutions - McAllen
California
- California Heart & Vascular Clinic - El Centro
- Merced Vein & Vascular Center - Merced
Florida
- The Cardiac & Vascular Institute - Gainesville
- Vascardio Heart and Vascular Institute - Hialeah
Illinois
- MIMIT Health - Chicago
- MIMIT Health - Glen Ellyn
Michigan
- Eastlake Cardiovascular - Roseville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2022-11-17 |
| Phase | NA |
What the finished NCT04241224 record still lists
NCT04241224 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which Atherectomy is the first listed.
NCT04241224 lists 10 locations in 5 states (Texas, California, Florida).
Frequently Asked Questions
What is clinical trial NCT04241224 about?
NCT04241224 is a clinical study titled "A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages". To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
What is the current status of trial NCT04241224?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2020-02-26. Estimated completion is 2022-11-17.
What conditions does trial NCT04241224 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT04241224?
The interventions under investigation include: Atherectomy (DEVICE).
Who is sponsoring clinical trial NCT04241224?
This trial is sponsored by Ra Medical Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04241224 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04241224's enrollment target sits among peer trials
108 37th of 79 higher than 42 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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