- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692402
Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome (Solitaire)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: cathy Haiyan li, Master Degree
- Phone Number: +65 63578388
- Email: Haiyan_LI@ttsh.com.sg
Study Contact Backup
- Name: Iswarya Jayakumar, Degree
- Phone Number: 63578326
- Email: Iswarya_JAYAKUMAR@ttsh.com.sg
Study Locations
-
-
-
Singapore, Singapore, 768828
- Recruiting
- Khoo Teck Puat Hospital
-
Contact:
- Boon Khim Lim
- Phone Number: (65)66023307
- Email: lim.boon.khim@ktph.com.sg
-
Principal Investigator:
- Dr Syed Saqib Imran
-
Singapore, Singapore, 119074
- Recruiting
- National University Heart Centre Singapore (NUHCS)
-
Contact:
- Jolene Leong
- Email: jolene_rachel_LEONG@nuhs.edu.sg
-
Principal Investigator:
- Dr Joshua LOH
-
Singapore, Singapore, 308433
- Recruiting
- Tan Tock Seng Hospital (TTSH)
-
Contact:
- Haiyan Li
- Phone Number: (65)63578388
- Email: Haiyan_LI@ttsh.com.sg
-
Principal Investigator:
- Dr Paul Jau Lueng Ong
-
Singapore, Singapore, 529889
- Recruiting
- Changi General Hospital (CGH) Changi General Hospital
-
Contact:
- Li Li
- Phone Number: (65)68502697
- Email: Li_Li@cgh.com.sg
-
Principal Investigator:
- Dr Yew Seong Goh
-
-
Singaproe
-
Singapore, Singaproe, Singapore, 169609
- Recruiting
- National Heart Centre Singapore (NHCS)
-
Contact:
- Aishah Toh
- Phone Number: (65)67042282
- Email: aishah.toh@nhcs.com.sg
-
Principal Investigator:
- Dr Aaron Sung Lung Wong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: open label
open label prospective feasibility trial.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
immediate post-procedure
|
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.
|
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
|
up to 30 days
|
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
|
at 24 hours ± 8 hours post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of successful thrombus resolution defined as an immediate post-procedure thrombus burden of thrombus grade (TG) 1 or less
Time Frame: immediate post-procedure
|
Secondary Endpoints
|
immediate post-procedure
|
Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.
Time Frame: immediate post-procedure
|
Secondary Endpoints
|
immediate post-procedure
|
Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more
Time Frame: immediate post-procedure
|
Secondary Endpoints
|
immediate post-procedure
|
Rate of device success defined as successful delivery and retrieval of the device without complication
Time Frame: immediate post- procedure
|
Secondary Endpoints
|
immediate post- procedure
|
Occurrence of major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: 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.
|
up to one year post-procedure
|
All-cause mortality through 90 days post procedure.
Time Frame: 90 days post procedure
|
Secondary Endpoints
|
90 days post procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul Jau Lueng Ong, Paul Ong Jau Lueng
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSRB 2018/00865
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractory Thrombus in Patients With Acute Coronary Syndrome
-
Heidelberg UniversityDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyUnknownPatients With Acute Coronary SyndromeGermany
-
Assiut UniversityRecruiting
-
Fundación Canaria Rafael Clavijo para la Investigación...CompletedPatients With Acute Coronary SyndromeSpain
-
Masonic Cancer Center, University of MinnesotaRecruitingMyelodysplastic Syndromes | Leukemia | Previously Treated Myelodysplastic Syndrome | Secondary Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia in Remission | Childhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Myeloid Leukemia | Secondary Myelodysplastic Syndrome and other conditionsUnited States
-
Assistance Publique - Hôpitaux de ParisUnknownRefractory Ascites in Patients With CirrhosisFrance
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedChronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | Adult Acute Myeloid Leukemia With Del(5q) | Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult... and other conditionsUnited States
-
Sohag UniversityNot yet recruitingPrediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose IndexEgypt
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Chronic Myelomonocytic Leukemia | Previously Treated Myelodysplastic Syndrome | Adult Acute Myeloid Leukemia in Remission | Adult Acute Lymphoblastic Leukemia in Remission | Refractory Anemia With Excess Blasts | Refractory... and other conditionsUnited States
-
Yonsei UniversityCompletedA Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.Korea, Republic of
-
National Institute of Cardiovascular Diseases,...RecruitingAcute Coronary Syndrome | Left Ventricular ThrombusPakistan
Clinical Trials on Solitaire™ thrombus retrieval device
-
Medtronic Neurovascular Clinical Affairsev3 InternationalCompleted
-
Medtronic Neurovascular Clinical AffairsCompletedIschemic StrokeUnited States
-
Jinling Hospital, ChinaCompleted
-
NeuroVasc TechnologiesRecruitingAcute Ischemic StrokeUnited States
-
Gregory W AlbersMedical University of South Carolina; National Institute of Neurological Disorders... and other collaboratorsTerminatedCerebral Infarction | Stroke, AcuteUnited States
-
Yokohama City University Medical CenterTeikyo UniversityCompleted
-
Universität des SaarlandesCompletedAcute StrokeGermany
-
Zhuhai Tonbridge Medical Tech. Co., Ltd.Guangzhou Osmunda Medical Device Technology, Inc., Ltd.CompletedIschemic StrokeChina
-
Suzhou Zenith Vascular Scitech Co., Ltd.CompletedAcute Ischemic Stroke | Large Vessel Occlusion | AIS | ThrombectomyChina
-
MIVI Neuroscience, Inc.WithdrawnStroke | Cerebrovascular Disorders | Stroke, Ischemic | Stroke, Acute | Cerebrovascular Accident