N/A
N=71
Side Branch FFR After Provisional Stenting
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03115580 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Side Branch Compromise — 7; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rotational atherectomy (Device); Cutting Balloon Angioplasty (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Side Branch Compromise |
7; 9 | — |
| SECONDARY Number of Participants With SB Dissection |
1; 0 | — |
| SECONDARY Number of Participants With TIMI < 3 |
3; 5 | — |
| SECONDARY Number of Participants With SB DS >70% |
2; 4 | — |
| SECONDARY Number of Participants With FFR Device Success |
28; 27 | — |
| SECONDARY Number of Patients With FFR Wire Workhorse Capability |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 2 mm by coronary angiogram.
- The target vessel must have a Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03115580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.