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COMPLETED

Imaging-Guided Vessel Sizing in the Tibial Arteries

NCT04748965 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2021-08-16
Est. Completion 2024-06-09

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04748965

The ClinicalTrials.gov registry entry for NCT04748965 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04748965 reports 3 study locations spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04748965?

The interventions under investigation include: Digital Subtraction Angiography (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04748965?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial