Coronary Artery, Platelet, Stent Thrombosis, Thrombus
Conditions
Keywords
Stent Thrombosis, Percutaneous Coronary Intervention, Bare Metal Stent, Drug Eluting Stent, Residual Platelet Reactivity, Optical Coherence Tomography, OCT
Brief summary
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.
Interventions
DEVICEOCT guided PCI
OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
DRUGOCT guided medical therapy
OCT guided medical therapy. Tailored antiplatelet therapy.
Sponsors
Careggi Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of uncovered stent struts | After thrombectomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of malapposed stent struts | After Thrombectomy | 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. |
| Percentage of patients with high residual platelet reactivity | Baseline | 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. |
Countries
Italy
Outcome results
None listed