N/A
N=30
Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02364778 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Jul 2016
Primary outcome: Primary: MLD SB Diameter — 08.; 1.0; 2.3; 2.2 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MLD SB Diameter |
08.; 1.0; 2.3; 2.2 | — |
| SECONDARY SB Angle |
140.3; 147.7; 140.5; 141.5; 48.0; 49.9 | — |
| SECONDARY SB Ostial Involvement |
1.4; 1.6; 0.8; 1.8 | — |
| SECONDARY Diameter Stenosis (DS) |
30.0; 24.0; 63.1; 27.7 | — |
Summary
This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.
Eligibility Criteria
Inclusion Criteria
- Over 18 years of age presenting with stable coronary artery disease.
- Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited
Exclusion Criteria
- Patient with lesion involving side branch ( >70 %) by angiogram and need pre-dilation.
- 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 (NCT02364778). 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.