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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01410539
Other study ID # MOST Study
Secondary ID
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


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
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