Mechanism Of Stent Thrombosis (MOST) Study

Study Overview
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Brief Summary
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This study is designed to assess the pathophysiology of ST by studying the main procedural and anatomical factors involved in the genesis of ST such as those related to stent and the vascular wall, as well as to the individual platelet residual reactivity.

Official Title
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Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry

Conditions
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Coronary Artery, Stent Thrombosis, Platelet, Thrombus

Intervention / Treatment
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* Device: OCT guided PCI
* Drug: OCT guided medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: previous PCI with bare metal stent (BMS) or drug eluting stent (DES) and a definite subacute coronary ST previous PCI with DES and a definite late or very late coronary ST Exclusion Criteria: Development of ST within 72 hours of stent implantation (acute and early subacute ST). Late and very late ST of BMS. Absence of informed consent. Age less than 18 years. Creatinine values greater than 2.5 g/dl (this is to avoid the negative effects related to the contrast medium necessary to perform the OCT evaluation).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent Thrombosis<br>Consecutive patients with stent thrombosis with stent strut assessment by OCT | Device: OCT guided PCI<br>* OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).<br>|
| Active Comparator: Controls<br>Control subjects without stent thrombosis from the RHR OCT database | Drug: OCT guided medical therapy<br>* OCT guided medical therapy. Tailored antiplatelet therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered stent struts | The percentage of uncovered stent struts by OCT in patients with subacute stent thrombosis (either DES and BMS) and the percentage of uncovered stent struts in patients with late (after one month) and very late thrombosis of DES. | After thrombectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of malapposed stent struts | The percentage of malapposed stent struts by OCT in patients with subacute thrombosis of DES and BMS and the percentage of malapposed stent struts by OCT in patients with late and very late thrombosis of DES. | After Thrombectomy | 
| Percentage of patients with high residual platelet reactivity | The percentage of patients with residual platelet reactivity (RPR) to ADP and arachidonic acid identified by values ≥ 240 P2Y12 reaction units (PRU) and ≥ 550 aspirin reaction units (ARU), respectively,. during aspirin and clopidogrel therapy or in which one or both the antiplatelet drugs have been interrupted. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, Stent Thrombosis, Percutaneous Coronary Intervention, Bare Metal Stent, Drug Eluting Stent, Residual Platelet Reactivity, Optical Coherence Tomography