Side Branch FFR After Provisional Stenting

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

The purpose of this study is to predict any changes in the side branch after stenting the main branch blood vessel using three dimensional intravascular images. (Frequency domain optical coherence tomography FD OCT). Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels. These images will be used before and after implanting the stent in the main blood vessel. Fractional Flow Reserve (FFR) test, which makes it possible for the interventional cardiologist to calculate blood flow across an area of a coronary artery, will be done after stenting and will help to determine if there are any changes in the side branch blood flow.

Key facts

Study ID

NCT03115580

Run by

Icahn School of Medicine at Mount Sinai

People needed

71

Starts

2017-05-02

Expected to finish

2019-03-26

Last updated by the study team

2020-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients over 18 years of age presenting with stable coronary artery disease.
• Patients must have a clinical indication for coronary intervention.
• Creatinine Kinase Myocardial-Band Isoenzyme (CK-MB) must be less than or equal to the upper limit of lab normal (ULN) value within eight hours prior to the procedure.
• The target lesion must be a de novo calcified bifurcation coronary lesion that hasn't been previously treated with any interventional procedure for which provisional main vessel stenting strategy is planned after reviewing angiogram.
• The target vessel must be a native coronary artery with
• stenosis ≥70% and <100%, or
• Stenosis ≥50% and <70% with evidence of clinical ischemia via positive stress test, or FFR ≤ 0.8, or IVUS or OCT minimal lumen area ≤ 4.0 mm2.
• The target lesion should have SB DS 30 - 70%.
• The target main vessel reference diameter must be ≥2.5 mm and ≤ 4.0 mm.
• The SB reference diameter must be > 2 mm by coronary angiogram.
• The target vessel must have a Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline.

You may not qualify if…

• Patients with ostial left main artery lesions or ostial right coronary artery lesions
• Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Known allergy to acetylsalicylic acid or clopidogrel.
• Planned surgery within 12 months.
• History of bleeding diathesis
• Major surgery within 15 days
• Life expectancy < 12 months.
• Patients with kidney dysfunction (CrCl<30)

Where it is running

• Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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