Stent Thrombosis Clinical Trial
— MostOfficial title:
Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry
Verified date | September 2014 |
Source | Careggi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Careggi Hospital, Department of Hearth and Vessels | Florence |
Lead Sponsor | Collaborator |
---|---|
Careggi Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
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