Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Dr Keyur Parikh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient who has been implanted with MeRes100 BRS from February 2021 to March 2023. 2. Patient has given written informed consent for participation prior to enrolment. 3. Patient is willing to undergo all study procedures and follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Any condition, which in the Investigator’s opinion would preclude safe participation of patient in the study. 2. Patient participating in another clinical investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area stenosis: Area stenosis is calculated as the reference minus the minimal lumen area as a percentage of the reference lumen area. The reference vessel lumen area is calculated as the average of the mean proximal and mean distal vessel areasTimepoint: Mean Follow up The study will prospectively assess outcomes of patients implanted with MeRes100 BRS from Feb 2021 to Mar 2023. CT angiography will be conducted with patient consent, at least one year post-procedure. Mean follow-up is defined as the timeframe for assessing CT outcomes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Minimal lumen diameter The minimal lumen diameter is defined as lumen diameter at the point of maximal obstruction mm 2 Diameter stenosis Percent Diameter Stenosis percent DS is defined as the value calculated as 100 multiply 1 minus MLD divide by Reference lumen diameter 3 Minimal lumen area The minimal lumen area is defined as lumen area at the point of maximal obstruction mm 4 Plaque volume Defined as vessel volume minus lumen volume 5 Remodeling Index Defined as ratio between vessel area including lumen at the site of maximum lumen stenosis & normal vessel proximal reference area arterial remodeling index equals to lesion plaque area divide by reference area 6 Plaque burden Defined as the ratio between cross sectional plaque area at the site of maximum stenosis & cross sectional vessel area at the same site plaque burden equals to cross sectional vessel area minus cross sectional lumen area divide by cross sectional vessel areaTimepoint: Mean Follow up The study will prospectively assess outcomes of patients implanted with MeRes100 BRS from Feb 2021 to Mar 2023 CT angiography will be conducted with patient consent at least one year post procedure Mean follow up is defined as the timeframe for assessing CT outcomes | — |
Countries
India
Contacts
Public ContactDr Keyur Parikh
Marengo CIMS Hospital Pvt Ltd
Outcome results
None listed