CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 71 enrolled
Drug / intervention
Rotational atherectomy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03115580
NCT03115580N/ACompleted

Optical Coherence Tomography Predictors of Functionally Significant Side Branch Compromise After Provisional Main Vessel Stenting In Calcific Coronary Artery Disease Assessed by Fractional Flow Reserve

Icahn School of Medicine at Mount Sinai·interventional·Posted Apr 14, 2017·Updated May 14, 2020

In Brief

A clinical study evaluating Rotational atherectomy and Cutting Balloon Angioplasty for Coronary Artery Disease. Completed, enrolled 71 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 14, 2017
Enrollment StartMay 2, 2017
Primary CompletionMar 26, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.2 years ago

Interventions

Rotational atherectomydevice

Rotational atherectomy for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.

Cutting Balloon Angioplastydevice

Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon