Refractory Thrombus in Patients With Acute Coronary Syndrome
Conditions
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 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.
Interventions
DEVICESolitaire™ 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.
Sponsors
Paul Ong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Investigator initiated multicentre open label prospective feasibility trial.
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects meeting all of the inclusion criteria listed below will be included in this study: 1. Index event of ST segment elevation or non-ST segment elevation MI or Unstable Angina defined as: 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
Subjects meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3. | immediate post-procedure | Primary Efficacy Endpoint |
| Occurrence of any stroke | immediate post-procedure up to 30 days | Occurrence of any stroke, defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours, from immediate post-procedure up to 30 days. |
| Incidence of study device-related Serious Adverse Events (SAEs) up to 30 days. | up to 30 days | Primary Safety Endpoint |
| Incidence of emboli in new territory (ENT) at 24 hrs ± 8 hrs post procedure (ENT: Embolization territories outside of the target downstream territory). | at 24 hours ± 8 hours post procedure | Primary Safety Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of major adverse cardiac and cerebrovascular events (MACCE) | up to one year post-procedure | Occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as composite of all cause death, myocardial infarction, target vessel revascularisation or stroke, up to one year post-procedure. |
| Rate of successful thrombus resolution defined as an immediate post-procedure thrombus burden of thrombus grade (TG) 1 or less | immediate post-procedure | Secondary Endpoints |
| All-cause mortality through 90 days post procedure. | 90 days post procedure | Secondary Endpoints |
| Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device. | immediate post-procedure | Secondary Endpoints |
| Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more | immediate post-procedure | Secondary Endpoints |
| Rate of device success defined as successful delivery and retrieval of the device without complication | immediate post- procedure | Secondary Endpoints |
Countries
Singapore
Contacts
Primary Contactcathy Haiyan li, Master Degree
Backup ContactIswarya Jayakumar, Degree
Outcome results
None listed