Most: Mechanism Of Stent Thrombosis (MOST) Study

Sponsor

Careggi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01410539

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Stent Thrombosis Platelet Thrombus	Device: OCT guided PCI Drug: OCT guided medical therapy	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stent Thrombosis Consecutive patients with stent thrombosis with stent strut assessment by OCT	Device: OCT guided PCI OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
Active Comparator: Controls Control subjects without stent thrombosis from the RHR OCT database	Drug: OCT guided medical therapy OCT guided medical therapy. Tailored antiplatelet therapy.

Arm

Intervention/Treatment

Experimental: Stent Thrombosis

Consecutive patients with stent thrombosis with stent strut assessment by OCT

Device: OCT guided PCI

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

Active Comparator: Controls

Control subjects without stent thrombosis from the RHR OCT database

Drug: OCT guided medical therapy

OCT guided medical therapy. Tailored antiplatelet therapy.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).