Mechanism Of Stent Thrombosis (MOST) Study (Most)

Careggi Hospital

Status and phase: Completed; Phase 4

Conditions: Coronary Artery; Platelet; Thrombus; Stent Thrombosis

Treatments: Device: OCT guided PCI; Drug: OCT guided medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01410539

MOST Study

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Stent Thrombosis

Experimental group

Description:

Consecutive patients with stent thrombosis with stent strut assessment by OCT

Treatment:

Device: OCT guided PCI

Controls

Active Comparator group

Description:

Control subjects without stent thrombosis from the RHR OCT database

Treatment:

Drug: OCT guided medical therapy