NCT01914055

Brief Summary

demonstrate that FD-OCT guidance is feasible and possibly results in reduction of frequency-domain Optical Coherence Tomography-defined residual thrombus burden after thrombus-aspiration.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

July 12, 2013

Last Update Submit

October 21, 2013

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography

    Whether FD-OCT guidance of manual thrombus aspiration (TA) is superior to conventional angio-guided TA in reducing residual thrombus burden after stenting (defined as the number of cross-sections with thrombus area more than 10% at post-stenting FD-OCT)

    within the primary PCI procedure

Secondary Outcomes (1)

  • major adverse cardiac events

    at 6 months

Study Arms (2)

angio-guided thrombus aspiration

ACTIVE COMPARATOR

thrombus aspiration guided by angiography

Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)

OCT-guided thrombus aspiration

EXPERIMENTAL

thrombus aspiration guided by optical coherence tomography

Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)

Interventions

angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)DEVICE

angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)

angio-guided thrombus aspiration
OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)DEVICE

FD-OCT-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan); OCT images will be acquired at the site of culprit coronary artery with a commercially available system (Lunawave System; Fastview catheter/Terumo, Tokio, Japan OR C7 System; LightLab Imaging Inc; C7 Dragonfly catheter/St Jude Medical, Westford, MA)

OCT-guided thrombus aspiration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ST elevation myocardial infarction
  • Ages Eligible for Study: \>18 years old
  • Genders Eligible for Study: Both (female sex with child-bearing potential excluded)

You may not qualify if:

  • occluded (TIMI 0) or sub occluded (TIMI 1) proximal vessel of estimated diameter ≥3mm
  • intended use of thrombus aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

RECRUITING

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 12, 2013

First Posted

August 1, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

IT(1)