Status:
UNKNOWN
Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome
Lead Sponsor:
Paul Ong
Conditions:
Refractory Thrombus in Patients With Acute Coronary Syndrome
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04692402
Start Date
July 16 2019
End Date
September 30 2022
Last Update
December 31 2020
Active Locations (5)
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1
National Heart Centre Singapore (NHCS)
Singapore, Singaproe, Singapore, 169609
2
National University Heart Centre Singapore (NUHCS)
Singapore, Singapore, 119074
3
Tan Tock Seng Hospital (TTSH)
Singapore, Singapore, 308433
4
Changi General Hospital (CGH) Changi General Hospital
Singapore, Singapore, 529889