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NCT04748965 · ClinicalTrials.gov registry record
Imaging-Guided Vessel Sizing in the Tibial Arteries
A clinical trial of Peripheral Artery Disease and Critical Limb Ischemia, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- 40
- Enrollment target
- 3
- Study locations
NCT04748965: Completed study of Peripheral Artery Disease and Critical Limb Ischemia, sponsored by University Hospitals Cleveland Medical Center.
NCT04748965 is a study of Peripheral Artery Disease and Critical Limb Ischemia that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 40 participants, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (68% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04748965, a study of Peripheral Artery Disease and Critical Limb Ischemia, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. Secondary comparison with intravascular ultrasound (IVUS) is undertaken when clinically feasible. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.
Primary Outcome
To develop a protocolized, reproducible technique to maximize the Clear Image Length (CIL) on 75 mm pullbacks using 100% contrast in the tibial arteries. The goal is to compare intravascular ultrasound (IVUS) and optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. The hypothesis is that the adjunctive use of intravasc
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Digital Subtraction Angiography
Study Locations (3)
Ohio
- University Hospitals Ahuja Medical Center - Beachwood
- University Hospitals Cleveland Medical Center - Cleveland
- University Hospitals Parma Medical Center - Parma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2024-06-09 |
What the finished NCT04748965 record still lists
NCT04748965 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Digital Subtraction Angiography is the first listed.
NCT04748965 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04748965 about?
NCT04748965 is a clinical study titled "Imaging-Guided Vessel Sizing in the Tibial Arteries". This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determinin...
What is the current status of trial NCT04748965?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2021-08-16. Estimated completion is 2024-06-09.
What conditions does trial NCT04748965 study?
This clinical trial studies the following conditions: Peripheral Artery Disease, Critical Limb Ischemia.
What interventions are being tested in trial NCT04748965?
The interventions under investigation include: Digital Subtraction Angiography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04748965?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04748965 being conducted?
This trial has 3 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04748965's enrollment target sits among peer trials
40 29th of 50 higher than 20 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery 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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