Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Refractory Thrombus in Patients With Acute Coronary Syndrome
- Sponsor
- Paul Ong
- Enrollment
- 51
- Locations
- 5
- Primary Endpoint
- Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3.
- Last Updated
- 5 years ago
Overview
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.
Investigators
Paul Ong
Consultant Cardiologist and Cathlab Director
Tan Tock Seng Hospital
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3.
Time Frame: immediate post-procedure
Primary Efficacy Endpoint
Occurrence of any stroke
Time Frame: 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.
Time Frame: 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).
Time Frame: at 24 hours ± 8 hours post procedure
Primary Safety Endpoint
Secondary Outcomes
- Rate of device success defined as successful delivery and retrieval of the device without complication(immediate 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)
- Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.(immediate post-procedure)
- Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more(immediate post-procedure)
- Occurrence of major adverse cardiac and cerebrovascular events (MACCE)(up to one year post-procedure)
- All-cause mortality through 90 days post procedure.(90 days post procedure)