Feasibility Trial Evaluating Efficacy and Safety of Solitaire Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome
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- STATUS
- Recruiting
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- days left to enroll
- 90
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- participants needed
- 51
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- sponsor
- Paul Ong
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.
- Primary Objectives To evaluate intra-procedure efficacy of using Solitaire in ACS patients with refractory thrombus.
- 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 Identifier | NCT04692402 |
| Sponsor | Paul Ong |
| Last Modified on | 27 January 2021 |
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