Mechanism Of Stent Thrombosis (MOST) Study

Phase 4

Completed

• Conditions: Coronary Artery; Stent Thrombosis; Platelet; Thrombus
• Interventions: Device: OCT guided PCI; Drug: OCT guided medical therapy

• Registration Number: NCT01410539
• Lead Sponsor: Careggi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-08
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Study Completion: 2011-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent Thrombosis	OCT guided PCI	Consecutive patients with stent thrombosis with stent strut assessment by OCT
Controls	OCT guided medical therapy	Control subjects without stent thrombosis from the RHR OCT database

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Careggi Hospital, Department of Hearth and Vessels; 🇮🇹 Florence, Italy