Refractory Thrombus in Patients With Acute Coronary SyndromeSolitaireNCT04692402
Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome
A study testing Solitaire™ thrombus retrieval device in people with Refractory Thrombus in Patients With Acute Coronary Syndrome, run by Paul Ong at 5 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Refractory Thrombus in Patients With Acute Coronary Syndrome
- What is being tested?
- Solitaire™ thrombus retrieval device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesSingapore
- Study dates
- 16 Jul 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 .
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Singapore5 sites, 5 recruiting
- Recruiting
National Heart Centre Singapore (NHCS)
Singapore, Singaproe, 169609
Aishah Toh, (65)67042282, aishah.toh@nhcs.com.sg
Dr Aaron Sung Lung Wong
- Recruiting
National University Heart Centre Singapore (NUHCS)
Singapore, 119074
Jolene Leong, jolene_rachel_LEONG@nuhs.edu.sg
Dr Joshua LOH
- Recruiting
Tan Tock Seng Hospital (TTSH)
Singapore, 308433
Haiyan Li, (65)63578388, Haiyan_LI@ttsh.com.sg
Dr Paul Jau Lueng Ong
- Recruiting
Changi General Hospital (CGH) Changi General Hospital
Singapore, 529889
Li Li, (65)68502697, Li_Li@cgh.com.sg
Dr Yew Seong Goh
- Recruiting
Khoo Teck Puat Hospital
Singapore, 768828
Boon Khim Lim, (65)66023307, lim.boon.khim@ktph.com.sg
Dr Syed Saqib Imran
About this study
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.
Read the 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.
- Being tested
- Solitaire™ thrombus retrieval device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solitaire™ thrombus retrieval deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| open label | Other | open label prospective feasibility trial. Receives: Device: Solitaire™ thrombus retrieval device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3.
Primary Efficacy Endpoint
Measured: immediate post-procedure
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.
Measured: immediate post-procedure up to 30 days
Incidence of study device-related Serious Adverse Events (SAEs) up to 30 days.
Primary Safety Endpoint
Measured: 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).
Primary Safety Endpoint
Measured: at 24 hours ± 8 hours post procedure
Secondary outcomes (6)
Rate of successful thrombus resolution defined as an immediate post-procedure thrombus burden of thrombus grade (TG) 1 or less
Secondary Endpoints
Measured: immediate post-procedure
Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.
Secondary Endpoints
Measured: immediate post-procedure
Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more
Secondary Endpoints
Measured: immediate post-procedure
Rate of device success defined as successful delivery and retrieval of the device without complication
Secondary Endpoints
Measured: immediate post- procedure
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.
Measured: up to one year post-procedure
All-cause mortality through 90 days post procedure.
Secondary Endpoints
Measured: 90 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start16 Jul 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Thrombus in Patients With Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Ong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Ong, Tan Tock Seng Hospital
- Investigators
- Paul Jau Lueng Ong, Principal investigator, Paul Ong Jau Lueng
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692402
- Sponsor's protocol ID
- DSRB 2018/00865
- Acronym
- Solitaire
- Status last verified
- Dec 2020
- First submitted
- 28 Oct 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04692402
- Acronym / sponsor ID
- Solitaire / DSRB 2018/00865
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Paul OngUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Other | Device: Solitaire™ thrombus retrieval deviceopen label prospective feasibility trial. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solitaire™ thrombus retrieval deviceAfter 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. | Device | open label |
Primary outcome
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
6 secondary outcomes
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
Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.
Time frame: 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
Rate of device success defined as successful delivery and retrieval of the device without complication
Time frame: immediate post- procedure
Occurrence of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: up to one year post-procedure
All-cause mortality through 90 days post procedure.
Time frame: 90 days post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Jau Lueng Ong principal investigator
Paul Ong Jau Lueng
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solitaire™ thrombus retrieval device in people with Refractory Thrombus in Patients With Acute Coronary Syndrome, run by Paul Ong at 5 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cathy Haiyan li, Master Degree (+65 63578388, Haiyan_LI@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.