Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses

NCT04019535 | Completed

• 1 other identifier: 201810120
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Physiologic assessment

Outcome Measures

Primary Outcomes (2)

• Correlation of iFR and DFR

  . DFR will be correlated, in VIVO, with the gold standard, diastolic coronary blood flow measurement, the instantaneous wave free ratio (iFR). Both DFR and iFR will be correlated simultaneously during the index procedure in patients with moderate coronary stenoses whom hemodynamic assessment was clinically indicated.

  The correlation between values will be the primary endpoint measured and occurs only during the index procedure.

• Agreement for treatment with iFR

  . how many patients would be treated differently using iFR vs. DFR

  after all subjects are enrolled the RedCap data will be evaluated

Interventions

physiological assessment with Volcano Verrata pressure wire (iFR) DEVICE

physiological assessment of the coronary lesion will be made with both iFR and dFR. all clinical decisions will be made based on the results of iFR

Also known as: physiological assessment with Boston Scientific Comet pressure wire (dFR)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Marc Sintek, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: July 15, 2019
• Study Start: August 22, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (1)