Mechanism Of Stent Thrombosis (MOST) Study

Stent Thrombosis Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410539
• Other study ID #: MOST Study
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2011
• Last updated: September 24, 2014
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: September 2014
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery
• Platelet
• Stent Thrombosis
• Thrombosis
• Thrombus

Intervention

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

Drug:
• OCT guided medical therapy
OCT guided medical therapy. Tailored antiplatelet therapy.

Locations

Country	Name	City	State
Italy	Careggi Hospital, Department of Hearth and Vessels	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Careggi Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Percentage of malapposed stent struts	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.	After Thrombectomy	Yes
Secondary	Percentage of patients with high residual platelet reactivity	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.	Baseline	Yes