Feasibility Trial Evaluating Efficacy and Safety of Solitaire Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    51
  • sponsor
    Paul Ong
Updated on 27 January 2021

Summary

The study is designed as a multicentre open label prospective feasibility trial to capture preliminary efficacy and safety information on Solitaire device to plan an appropriate pivotal study.

Description

We hypothesize that Solitaire device could be effectively and safely used as an adjunctive interventional technique in ACS patients found to have refractory thrombus during PCI.

  1. Primary Objectives To evaluate intra-procedure efficacy of using Solitaire in ACS patients with refractory thrombus.
  2. Secondary Objectives To evaluate clinical efficacy of using Solitaire in ACS patients with refractory thrombus, up to one year post-procedure.

To evaluate safety of using Solitaire in ACS patients with refractory thrombus.

The target enrolment is 51 patients diagnosed with STEMI, NSTEMI or UA and found to have refractory thrombus during PCI. Eligible patients will be identified at the ED or Inpatient ward of the 5 participating hospitals. The projected enrolment period is for two years and follow up for one year. A screening log will be maintained at each site to keep record of patients who were eligible for the study but not enrolled, to establish any selection bias.

Details
Condition Refractory Thrombus in Patients With Acute Coronary Syndrome
Treatment Solitaire™ thrombus retrieval device
Clinical Study IdentifierNCT04692402
SponsorPaul Ong
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects meeting all of the inclusion criteria listed below will be included
in this study
Index event of ST segment elevation or non-ST segment elevation MI or Unstable Angina defined as
Presentation to hospital with symptoms of myocardial ischemia (Chest pain or angina equivalent) lasting for 10 minutes at rest
AND 1 of the following
\. Persistent ST segment elevation 1mm (0.1 mV) in two or more contiguous
limb leads or 2mm (0.2 mV) in ) in one or more contiguous precordial leads OR
\. New or presumed new left bundle branch block (LBBB) OR
\. ST segment depression 1mm (0.1 mV) in two or more contiguous leads (not
known to be pre-existing or due to a known cause such as LV hypertrophy or
digoxin) OR
\. Troponin T or I greater than the laboratory upper normal limit
\. Referred for urgent or emergency PCI AND Thrombus burden of TG 4 or above
OR TIMI flow grade of 1 or less in at least one native infarct related artery
following either
Manual aspiration thrombectomy OR
Balloon Angioplasty OR
AngioJet RT OR
Patient having deferred PCI due to heavy thrombus but continue to demonstrate recalcitrant thrombus upon repeat angiography

Exclusion Criteria

Subjects meeting any of the exclusion criteria listed below will be excluded
from this
study
Age 21 years
Cardiogenic shock
killip class 3 or above at presentation
Known relative contraindications for the use of Solitaire
Prior stent in infarct related artery
Significant proximal stenosis OR Ostial lesion at angiography
Extensive calcification
Life expectancy less than six months due to non-cardiac condition
Participants categorised as vulnerable subjects (ex: prisoners, pregnant women, and mentally disabled persons)
Patients at high risk of being lost to follow up (ex: non-residents)
Participation in any study with an investigational drug or device within the last 30 days
Patients who are unable to provide informed consent prior to any procedure
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