Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome
NCT ID: NCT04692402
Last Updated: 2020-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
51 participants
INTERVENTIONAL
2019-07-16
2022-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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open label
open label prospective feasibility trial.
Solitaire™ thrombus retrieval device
After consent has been obtained, interventional cardiologist selects the proper solitaire device size per device-specific instructions for use. Adjunctive intervention with Solitaire will be done with a maximum of 2 device deployments. Do not perform more than three recovery attempts in the same vessel using the devices (Maximum of 2 attempts per device per subject). Do not reposition each device more than two times. TIMI flow, thrombus grade and myocardial blush grade will be assessed immediately upon completion of procedure. If recanalization is deemed inadequate by the interventional cardiologist, rescue treatment will follow as per current clinical practice. All other procedures followed will be as clinically indicated.
Interventions
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Solitaire™ thrombus retrieval device
After consent has been obtained, interventional cardiologist selects the proper solitaire device size per device-specific instructions for use. Adjunctive intervention with Solitaire will be done with a maximum of 2 device deployments. Do not perform more than three recovery attempts in the same vessel using the devices (Maximum of 2 attempts per device per subject). Do not reposition each device more than two times. TIMI flow, thrombus grade and myocardial blush grade will be assessed immediately upon completion of procedure. If recanalization is deemed inadequate by the interventional cardiologist, rescue treatment will follow as per current clinical practice. All other procedures followed will be as clinically indicated.
Eligibility Criteria
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Inclusion Criteria
1. Presentation to hospital with symptoms of myocardial ischemia (Chest pain or angina equivalent) lasting for ≥10 minutes at rest
AND 1 of the following:
2. 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
3. New or presumed new left bundle branch block (LBBB) OR
4. 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
5. Troponin T or I greater than the laboratory upper normal limit.
2. 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
1. Manual aspiration thrombectomy OR
2. Balloon Angioplasty OR
3. AngioJet RT OR
4. Patient having deferred PCI due to heavy thrombus but continue to demonstrate recalcitrant thrombus upon repeat angiography.
Exclusion Criteria
2. Cardiogenic shock
3. killip class 3 or above at presentation
4. Known relative contraindications for the use of Solitaire:
1. Prior stent in infarct related artery
2. Significant proximal stenosis OR Ostial lesion at angiography
3. Extensive calcification
5. Life expectancy less than six months due to non-cardiac condition
6. Participants categorised as vulnerable subjects (ex: prisoners, pregnant women, and mentally disabled persons)
7. Patients at high risk of being lost to follow up (ex: non-residents)
8. Participation in any study with an investigational drug or device within the last 30 days
9. Patients who are unable to provide informed consent prior to any procedure .
22 Years
80 Years
ALL
No
Sponsors
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Paul Ong
OTHER
Responsible Party
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Paul Ong
Consultant Cardiologist and Cathlab Director
Principal Investigators
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Paul Jau Lueng Ong
Role: PRINCIPAL_INVESTIGATOR
Paul Ong Jau Lueng
Locations
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National Heart Centre Singapore (NHCS)
Singapore, Singaproe, Singapore
National University Heart Centre Singapore (NUHCS)
Singapore, , Singapore
Tan Tock Seng Hospital (TTSH)
Singapore, , Singapore
Changi General Hospital (CGH) Changi General Hospital
Singapore, , Singapore
Khoo Teck Puat Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Aishah Toh
Role: primary
Jolene Leong
Role: primary
Haiyan Li
Role: primary
Li Li
Role: primary
Boon Khim Lim
Role: primary
Other Identifiers
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DSRB 2018/00865
Identifier Type: -
Identifier Source: org_study_id