Mechanism Of Stent Thrombosis (MOST) Study

NCT01410539 | Completed Phase 4 DMC

• 1 other identifier: MOST Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery; Stent Thrombosis; Platelet; Thrombus

Keywords

Stent Thrombosis; Percutaneous Coronary Intervention; Bare Metal Stent; Drug Eluting Stent; Residual Platelet Reactivity; Optical Coherence Tomography; OCT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Percentage of malapposed stent struts

  After Thrombectomy

• Percentage of patients with high residual platelet reactivity

  Baseline

Study Arms (2)

Stent Thrombosis

EXPERIMENTAL

Consecutive patients with stent thrombosis with stent strut assessment by OCT

Device: OCT guided PCI

Controls

ACTIVE COMPARATOR

Control subjects without stent thrombosis from the RHR OCT database

Drug: OCT guided medical therapy

Interventions

OCT guided PCI DEVICE

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

Stent Thrombosis

OCT guided medical therapy DRUG

OCT guided medical therapy. Tailored antiplatelet therapy.

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Careggi Hospital: lead

Study Sites (1)

Careggi Hospital, Department of Hearth and Vessels

Florence, Italy

Location

Related Publications (1)

• 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.

  PMID: 24384290 DERIVED

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Antoniucci, MD

  Careggi Hospital, Division of Invasive Cardiology

  STUDY CHAIR

• Francesco Prati, MD

  Rome Heart Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Division of Invasive Cardiology

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 5, 2011
• Study Start: January 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

IT (1)