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Side Branch FFR After Provisional Stenting
NA trial testing Rotational atherectomy in Coronary Artery Disease in 71 participants. Completed in 26 March 2019.
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 71 |
| Start date | 2 May 2017 |
| Primary completion | 26 March 2019 |
| Estimated completion | 26 March 2019 |
| Sites | 1 location across United States |
Icahn School of Medicine at Mount Sinai
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with Side Branch (SB) compromise which is defined as SB DS \> 70%, or dissection or TIMI \< 3
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy | 7 | |
| CBA/PTCA | 9 |
Number of participants with SB dissection
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy | 1 | |
| CBA/PTCA | 0 |
Number of participants with TIMI flow grade \< 3
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy | 3 | |
| CBA/PTCA | 5 |
Number of participants with Side Branch Diameter Stenosis (DS) \> 70%
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy | 2 | |
| CBA/PTCA | 4 |
Number of Participants with successfully deliver Fractional Flow Reserve (FFR) wire to desired SB distal segment
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy | 28 | |
| CBA/PTCA | 27 |
FFR Wire Workhorse Capability - Number of patients in which FFR wire was able to serve as rail to deliver additional interventional devices to target SB lesion
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy | 0 | |
| CBA/PTCA | 0 |
Time frame: 1 Day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Rotational Atherectomy | CBA/PTCA |
|---|---|---|---|
| Chest Pain | Cardiac disorders | — | — |
| Transient sidebranch closing | Cardiac disorders | — | — |
| LM dissection with contrast injecting | Surgical and medical procedures | — | — |
| Right CFA access side bleeding | Surgical and medical procedures | — | — |
| Dissection Minor | Cardiac disorders | — | — |
| Side branch closure | Cardiac disorders | — | — |
| Staged PCI pf p:CS-OM1 | Cardiac disorders | — | — |
Data from ClinicalTrials.gov NCT03115580 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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