Back to resultsFeasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome (Solitaire)
Primary Purpose
Refractory Thrombus in Patients With Acute Coronary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Solitaire™ thrombus retrieval device
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Thrombus in Patients With Acute Coronary Syndrome
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
- Balloon Angioplasty OR
- AngioJet RT OR
- 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:
- 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 .
Sites / Locations
- National Heart Centre Singapore (NHCS)Recruiting
- National University Heart Centre Singapore (NUHCS)Recruiting
- Tan Tock Seng Hospital (TTSH)Recruiting
- Changi General Hospital (CGH) Changi General HospitalRecruiting
- Khoo Teck Puat HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
open label
Arm Description
open label prospective feasibility trial.
Outcomes
Primary Outcome Measures
Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3.
Primary Efficacy Endpoint
Occurrence of any stroke
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.
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).
Primary Safety Endpoint
Secondary Outcome Measures
Rate of successful thrombus resolution defined as an immediate post-procedure thrombus burden of thrombus grade (TG) 1 or less
Secondary Endpoints
Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.
Secondary Endpoints
Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more
Secondary Endpoints
Rate of device success defined as successful delivery and retrieval of the device without complication
Secondary Endpoints
Occurrence of major adverse cardiac and cerebrovascular events (MACCE)
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.
Secondary Endpoints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04692402
Brief Title
Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome
Acronym
Solitaire
Official Title
Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Ong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Thrombus in Patients With Acute Coronary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Investigator initiated multicentre open label prospective feasibility trial.
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open label
Arm Type
Other
Arm Description
open label prospective feasibility trial.
Intervention Type
Device
Intervention Name(s)
Solitaire™ thrombus retrieval device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3.
Description
Primary Efficacy Endpoint
Time Frame
immediate post-procedure
Title
Occurrence of any stroke
Description
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.
Time Frame
immediate post-procedure up to 30 days
Title
Incidence of study device-related Serious Adverse Events (SAEs) up to 30 days.
Description
Primary Safety Endpoint
Time Frame
up to 30 days
Title
Incidence of emboli in new territory (ENT) at 24 hrs ± 8 hrs post procedure (ENT: Embolization territories outside of the target downstream territory).
Description
Primary Safety Endpoint
Time Frame
at 24 hours ± 8 hours post procedure
Secondary Outcome Measure Information:
Title
Rate of successful thrombus resolution defined as an immediate post-procedure thrombus burden of thrombus grade (TG) 1 or less
Description
Secondary Endpoints
Time Frame
immediate post-procedure
Title
Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.
Description
Secondary Endpoints
Time Frame
immediate post-procedure
Title
Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more
Description
Secondary Endpoints
Time Frame
immediate post-procedure
Title
Rate of device success defined as successful delivery and retrieval of the device without complication
Description
Secondary Endpoints
Time Frame
immediate post- procedure
Title
Occurrence of major adverse cardiac and cerebrovascular events (MACCE)
Description
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.
Time Frame
up to one year post-procedure
Title
All-cause mortality through 90 days post procedure.
Description
Secondary Endpoints
Time Frame
90 days post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Balloon Angioplasty OR
AngioJet RT OR
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:
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cathy Haiyan li, Master Degree
Phone
+65 63578388
Email
Haiyan_LI@ttsh.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Iswarya Jayakumar, Degree
Phone
63578326
Email
Iswarya_JAYAKUMAR@ttsh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Jau Lueng Ong
Organizational Affiliation
Paul Ong Jau Lueng
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Heart Centre Singapore (NHCS)
City
Singapore
State/Province
Singaproe
ZIP/Postal Code
169609
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aishah Toh
Phone
(65)67042282
Email
aishah.toh@nhcs.com.sg
First Name & Middle Initial & Last Name & Degree
Dr Aaron Sung Lung Wong
Facility Name
National University Heart Centre Singapore (NUHCS)
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolene Leong
Email
jolene_rachel_LEONG@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Dr Joshua LOH
Facility Name
Tan Tock Seng Hospital (TTSH)
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Li
Phone
(65)63578388
Email
Haiyan_LI@ttsh.com.sg
First Name & Middle Initial & Last Name & Degree
Dr Paul Jau Lueng Ong
Facility Name
Changi General Hospital (CGH) Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Li
Phone
(65)68502697
Email
Li_Li@cgh.com.sg
First Name & Middle Initial & Last Name & Degree
Dr Yew Seong Goh
Facility Name
Khoo Teck Puat Hospital
City
Singapore
ZIP/Postal Code
768828
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boon Khim Lim
Phone
(65)66023307
Email
lim.boon.khim@ktph.com.sg
First Name & Middle Initial & Last Name & Degree
Dr Syed Saqib Imran
12. IPD Sharing Statement
Learn more about this trial
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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