The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in ST Segment Elevation Myocardial Infarction (STEMI) Patients Undergoing Primary Percutaneous Coronary Intervention (PPCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Delta index of microcirculatory resistance (dIMR)
Study Overview
Brief Summary
This study aims to assess the impact of NC balloon post-dilatation on coronary microcirculation in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
Detailed Description
Suboptimal stent deployment can lead to future stent failure. Thus, optimising stent deployment with non-compliant balloons (NC balloon) post dilatation (PD) at high pressures is an established strategy. In the context of ST segment elevation myocardial infarction (STEMI), PD has been correlated anecdotally with the no reflow phenomenon.
This study aims to determine the impact of stent post-dilation (PD) with NC balloons at high pressures on coronary microcirculation during PPCI by measuring the index of microcirculatory resistance (IMR) pre and post stent post-dilatation. Pre and post PD, an optical coherence tomography (OCT) study will be performed to assess stent deployment and identify parameters that predict the changes in IMR.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Delta index of microcirculatory resistance (dIMR)
Time Frame: index procedure
Delta index of microcirculatory resistance (dIMR) \[dΙΜΡ = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)\]
Secondary Outcomes
- Stent edge dissections(index procedure)
- Stent expansion(index procedure)
- Minimum stent area (MSA)(index procedure)
- Stent mal-apposition(index procedure)
- Intra-stent plaque protrusion and thrombus(index procedure)