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Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses
A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment.
Conditions:
🦠 Coronary Artery Disease
🗓️ Study Start (Actual) 22 August 2019
🗓️ Primary Completion (Estimated) 31 December 2022
✅ Study Completion (Estimated) 31 December 2022
👥 Enrollment (Estimated) 106
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
    • * Age 18-90 year old
    • * Single worst lesion per patient- Patients may have more than one lesion assessed but only 1 lesion will be evaluated per patient in this study

    Exclusion Criteria:

    • * STEMI- Angiographic severity of 40-70% that operator feels needs physiologic assessment in setting of STEMI or 48hours within STEMI
    • * Atrial fibrillation
    • * Inability to provide informed consent- No surrogate or healthcare proxy will be allowed to consent for this study
    • * Severe tortuosity- Vessel tortuosity that the operator feels would be difficult to pass 2 pressure wires down or where pseudo lesions may be formed.
    • * Saphenous Vein Graft Lesion
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 29 March 2019
  • First Submitted that Met QC Criteria 12 July 2019
  • First Posted 15 July 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 August 2022
  • Last Update Posted 24 August 2022
  • Last Verified August 2022
I'm interested ...!!