Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome

Not Applicable

• Conditions: Refractory Thrombus in Patients With Acute Coronary Syndrome
• Interventions: Device: Solitaire™ thrombus retrieval device

• Registration Number: NCT04692402
• Lead Sponsor: Paul Ong

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.

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2020-10-28
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-29
• Last Update Submitted: 2020-12-29
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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 exclusion criteria listed below will be excluded from this study:

1. Age ≤ 21 years

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label	Solitaire™ thrombus retrieval device	open label prospective feasibility trial.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of device success defined as successful delivery and retrieval of the device without complication	immediate post- procedure	Secondary Endpoints
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
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
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.
All-cause mortality through 90 days post procedure.	90 days post procedure	Secondary Endpoints

Trial Locations

Locations (5)

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