Mechanism Of Stent Thrombosis (MOST) Study

NCT ID: NCT01410539

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-10-31

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.

Detailed Description

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Conditions

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Coronary Artery Stent Thrombosis Platelet Thrombus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stent Thrombosis

Consecutive patients with stent thrombosis with stent strut assessment by OCT

Group Type EXPERIMENTAL

OCT guided PCI

Intervention Type DEVICE

OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).

Controls

Control subjects without stent thrombosis from the RHR OCT database

Group Type ACTIVE_COMPARATOR

OCT guided medical therapy

Intervention Type DRUG

OCT guided medical therapy. Tailored antiplatelet therapy.

Interventions

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OCT guided PCI

OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).

Intervention Type DEVICE

OCT guided medical therapy

OCT guided medical therapy. Tailored antiplatelet therapy.

Intervention Type DRUG

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Careggi Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Antoniucci

Head Division of Invasive Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Antoniucci, MD

Role: STUDY_CHAIR

Careggi Hospital, Division of Invasive Cardiology

Francesco Prati, MD

Role: PRINCIPAL_INVESTIGATOR

Rome Heart Research

Locations

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Careggi Hospital, Department of Hearth and Vessels

Florence, , Italy

Site Status

Countries

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Italy

References

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Parodi G, La Manna A, Di Vito L, Valgimigli M, Fineschi M, Bellandi B, Niccoli G, Giusti B, Valenti R, Cremonesi A, Biondi-Zoccai G, Prati F. Stent-related defects in patients presenting with stent thrombosis: differences at optical coherence tomography between subacute and late/very late thrombosis in the Mechanism Of Stent Thrombosis (MOST) study. EuroIntervention. 2013 Dec;9(8):936-44. doi: 10.4244/EIJV9I8A157.

Reference Type DERIVED
PMID: 24384290 (View on PubMed)

Other Identifiers

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MOST Study

Identifier Type: -

Identifier Source: org_study_id

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