ST-segment Elevation Myocardial InfarctionPhase 4SMARTNCT01281033
CompariSon of Manual Aspiration With Rheolytic Thrombectomy in Patients Undergoing Primary PCI. The SMART-PCI Trial
A Phase 4 study testing Manual Thrombectomy and AngioJet Rheolytic Thrombectomy (RT) System in people with ST-segment Elevation Myocardial Infarction and Thrombus, run by Careggi Hospital at 1 site in Italy.
Trial summary
To compare rheolytic thrombectomy (RT) with manual thrombus aspiration (MTA) in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of ST-segment elevation myocardial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction, Thrombus
- What is being tested?
- Manual Thrombectomy and AngioJet Rheolytic Thrombectomy (RT) System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2010to Mar 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical inclusion criteria:
- Patient is > 18 years of age.
- Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
- Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
- Patient provides written informed consent. Patient has no childbearing potential or is not pregnant
- Angiographic inclusion criteria:
- All patients with or without evidence of thrombus are eligible.
- Target artery has a reference vessel diameter 2.5 mm on visual assessment at baseline angiography.
Who cannot join
- Clinical exclusion criteria:
- Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
- Cardiogenic shock.
- Prior administration of thrombolysis for the current infarction.
- Participation in another study.
- Major surgery within past 6 weeks.
Show all 14Show fewer
- History of stroke within 30 days, or any history of hemorrhagic stroke.
- Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy.
- Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3).
- Patient unwilling to receive blood products
- Angiographic exclusion criteria:
- Previously stented IRA (stent thrombosis).
- Inability to identify the IRA.
- Severe vessel tortuosity that enables OCT assessment.
Trial locations and contacts
1 site in 1 country.
About this study
To compare rheolytic thrombectomy (RT) with manual thrombus aspiration (MTA) in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of ST-segment elevation myocardial infarction (STEMI). Due to this substrate, macro- and microembolization during percutaneous coronary intervention (PCI) in AMI is frequent and may result in obstruction of the microvessel network, and decreased efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or postdilation is the most simplistic approach to the problem of embolization, and may decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel embolization include thrombectomy before stent implantation, and the use of antiembolic devices (filters and occlusive devices with retrieval of thromboembolic material after stent implantation). Most concluded studies on removing of thrombus before stenting used manual aspiration catheters and meta-analyses derived from these studies support the use of manual thrombus aspiration (MTA) catheters in the setting of primary PCI. MTA is currently recommended in the setting of primary PCI as a Class II b recommendation; level of evidence B. Rheolytic thrombectomy (RT) using multiple jets of saline solution and aspiration based on the Bernoulli effect has been proven to be effective in decreasing major adverse events during PCI in saphenous vein grafts or native coronary arteries with angiographic evidence of thrombus, and 2 out of 3 concluded studies have shown a better reperfusion and clinical outcome in patients randomized to RT as compared to control.
Read the detailed description
The SMART Study is an on-label, randomized, 2-arms, prospective study in patients with STEMI undergoing primary PCI. Diagnosis of STEMI is based on ECG evidence of ischemic ST changes, clinical symptoms, and elevated CK and CK-MB cardiac enzymes. Patients who are eligible for the Study and who provide written informed consent will be included in the study.
Inclusion Criteria:
- Patient is > 18 years of age.
- Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
- Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
- Patient provides written informed consent.
- Patient has no childbearing potential or is not pregnant.
- Target artery has a reference vessel diameter of at least 2.5 mm on visual assessment at baseline angiography.
Exclusion Criteria:
- Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
- Cardiogenic shock.
- Prior administration of thrombolysis for the current infarction.
- Participation in another study.
- Major surgery within past 6 weeks.
- History of stroke within 30 days, or any history of hemorrhagic stroke.
- Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy.
- Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3).
- Patient unwilling to receive blood products.
- Previously stented IRA (stent thrombosis).
- Inability to identify the IRA.
- Severe vessel tortuosity that enables OCT assessment.
- Being tested
- Manual Thrombectomy, AngioJet Rheolytic Thrombectomy (RT) System
- Keywords
- primary PCI, ST-segment elevation myocardial infarction, thrombus aspiration
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ThrombectomyProcedure or surgery
Also called manual aspiration
In patients in the thrombus-aspiration group, this step is followed by the advancing of the 6-French Export Aspiration Catheter (Medtronic; crossing profile, 0.068 in.) into the target coronary segment during continuous aspiration.
AngioJet Rheolytic Thrombectomy (RT) SystemProcedure or surgery
Also called Mechanical Thrombectomy
The AngioJet Rheolytic Thrombectomy (RT) System consists of a drive unit console, disposable pump set, and disposable catheter. Thrombectomy is accomplished by the introduction of a pressurized high velocity saline stream through directed orifices in the catheter distal tip so that thrombus is entrained (Bernoulli effect), dissociated into small particles, and evacuated from the body through the catheter and associated tubing. The pump set consists of a high pressure pulsatile pump which is used to generate the flow necessary for the dissociation and evacuation of thrombus, an effluent bag for the collection and storage of thrombus debris, and associated tubing.
| Study group | Role | What they receive |
|---|---|---|
| thrombus-aspiration group | Active comparator | In patients in the thrombus-aspiration group, the thrombus-aspiration is manually performed. Receives: Procedure: Manual Thrombectomy |
| AngioJet Rheolytic Thrombectomy | Experimental | AngioJet Rheolytic Thrombectomy (RT) System consists of a drive unit console, disposable pump set, and disposable catheter. Receives: Procedure: AngioJet Rheolytic Thrombectomy (RT) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-thrombectomy thrombus burden as assessed by coronary OCT
OCT images analysis. The primary end-point of the study will be the number of thrombus containing vascular quadrants considering vascular slices.
Measured: baseline
Secondary outcomes (10)
Angiographic thrombus grade after thrombectomy
Measured: baseline
ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG
Measured: 30 minutes
Angiographic markers of reperfusion:TIMI flow grade, TIMI myocardial blush.
Measured: baseline
Procedural angiographic complications : distal embolization, no-reflow, perforation, dissection.
Measured: baseline
Infarct size and microvascular obstruction measured by MRI at 3-7 days
Measured: 3-7 days
Six-month MACE (death, reinfarction, TVR, stroke)
Measured: six months
Six-month binary angiographic restenosis (> 50%)
Measured: six months
Percent of malapposed struts at 6-month OCT follow-up
Measured: six months
Six-month left ventricular remodelling by 2D ECHO
Measured: six months
Twelve-month MACE or hospital admission for heart failure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiovascular Research Foundation, New York
- Responsible party
- Principal investigator, David Antoniucci, Careggi Hospital
- Investigators
- David Antoniucci, MD, Principal investigator, Careggi Hospital, Division of Invasive Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281033
- Sponsor's protocol ID
- SMART-PCI
- Acronym
- SMART
- Status last verified
- Jul 2013
- First submitted
- 18 Jan 2011
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parodi G, Valenti R, Migliorini A, Maehara A, Vergara R, Carrabba N, Mintz GS, Antoniucci D. Comparison of manual thrombus aspiration with rheolytic thrombectomy in acute myocardial infarction. Circ Cardiovasc Interv. 2013 Jun;6(3):224-30. doi: 10.1161/CIRCINTERVENTIONS.112.000172. Epub 2013 Jun 4.
PubMed 23735474
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompariSon of Manual Aspiration With Rheolytic Thrombectomy in Patients Undergoing Primary PCI. The SMART-PCI Trial
- ClinicalTrials.gov ID
- NCT01281033
- Acronym / sponsor ID
- SMART / SMART-PCI
- Keywords
- primary PCI, ST-segment elevation myocardial infarction, thrombus aspiration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Collaborators
- Cardiovascular Research Foundation, New York
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Jan 2011 (estimated)
- 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.
To compare rheolytic thrombectomy (RT) with manual thrombus aspiration (MTA) in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of ST-segment elevation myocardial infarction (STEMI). Due to this substrate, macro- and microembolization during percutaneous coronary intervention (PCI) in AMI is frequent and may result in obstruction of the microvessel network, and decreased efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or postdilation is the most simplistic approach to the problem of embolization, and may decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel embolization include thrombectomy before stent implantation, and the use of antiembolic devices (filters and occlusive devices with retrieval of thromboembolic material after stent implantation). Most concluded studies on removing of thrombus before stenting used manual aspiration catheters and meta-analyses derived from these studies support the use of manual thrombus aspiration (MTA) catheters in the setting of primary PCI. MTA is currently recommended in the setting of primary PCI as a Class II b recommendation; level of evidence B. Rheolytic thrombectomy (RT) using multiple jets of saline solution and aspiration based on the Bernoulli effect has been proven to be effective in decreasing major adverse events during PCI in saphenous vein grafts or native coronary arteries with angiographic evidence of thrombus, and 2 out of 3 concluded studies have shown a better reperfusion and clinical outcome in patients randomized to RT as compared to control.
Detailed description
The SMART Study is an on-label, randomized, 2-arms, prospective study in patients with STEMI undergoing primary PCI. Diagnosis of STEMI is based on ECG evidence of ischemic ST changes, clinical symptoms, and elevated CK and CK-MB cardiac enzymes. Patients who are eligible for the Study and who provide written informed consent will be included in the study.
Inclusion Criteria:
- Patient is > 18 years of age.
- Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
- Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
- Patient provides written informed consent.
- Patient has no childbearing potential or is not pregnant.
- Target artery has a reference vessel diameter of at least 2.5 mm on visual assessment at baseline angiography.
Exclusion Criteria:
- Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
- Cardiogenic shock.
- Prior administration of thrombolysis for the current infarction.
- Participation in another study.
- Major surgery within past 6 weeks.
- History of stroke within 30 days, or any history of hemorrhagic stroke.
- Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy.
- Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3).
- Patient unwilling to receive blood products.
- Previously stented IRA (stent thrombosis).
- Inability to identify the IRA.
- Severe vessel tortuosity that enables OCT assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thrombus-aspiration group | Active comparator | Procedure: Manual ThrombectomyIn patients in the thrombus-aspiration group, the thrombus-aspiration is manually performed. |
| AngioJet Rheolytic Thrombectomy | Experimental | Procedure: AngioJet Rheolytic Thrombectomy (RT) SystemAngioJet Rheolytic Thrombectomy (RT) System consists of a drive unit console, disposable pump set, and disposable catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is > 18 years of age.
- Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
- Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
- Patient provides written informed consent. Patient has no childbearing potential or is not pregnant
- All patients with or without evidence of thrombus are eligible.
Key exclusion criteria (14 listed)
- Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
- Cardiogenic shock.
- Prior administration of thrombolysis for the current infarction.
- Participation in another study.
- Major surgery within past 6 weeks.
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 |
|---|---|---|
| Manual ThrombectomyAlso: manual aspirationIn patients in the thrombus-aspiration group, this step is followed by the advancing of the 6-French Export Aspiration Catheter (Medtronic; crossing profile, 0.068 in.) into the target coronary segment during continuous aspiration. | Procedure or surgery | thrombus-aspiration group |
| AngioJet Rheolytic Thrombectomy (RT) SystemAlso: Mechanical ThrombectomyThe AngioJet Rheolytic Thrombectomy (RT) System consists of a drive unit console, disposable pump set, and disposable catheter. Thrombectomy is accomplished by the introduction of a pressurized high velocity saline stream through directed orifices in the catheter distal tip so that thrombus is entrained (Bernoulli effect), dissociated into small particles, and evacuated from the body through the catheter and associated tubing. The pump set consists of a high pressure pulsatile pump which is used to generate the flow necessary for the dissociation and evacuation of thrombus, an effluent bag for the collection and storage of thrombus debris, and associated tubing. | Procedure or surgery | AngioJet Rheolytic Thrombectomy |
Primary outcome
Post-thrombectomy thrombus burden as assessed by coronary OCT
Time frame: baseline
OCT images analysis. The primary end-point of the study will be the number of thrombus containing vascular quadrants considering vascular slices.
10 secondary outcomes
Angiographic thrombus grade after thrombectomy
Time frame: baseline
ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG
Time frame: 30 minutes
Angiographic markers of reperfusion:TIMI flow grade, TIMI myocardial blush.
Time frame: baseline
Procedural angiographic complications : distal embolization, no-reflow, perforation, dissection.
Time frame: baseline
Infarct size and microvascular obstruction measured by MRI at 3-7 days
Time frame: 3-7 days
Six-month MACE (death, reinfarction, TVR, stroke)
Time frame: six months
Six-month binary angiographic restenosis (> 50%)
Time frame: six months
Percent of malapposed struts at 6-month OCT follow-up
Time frame: six months
Six-month left ventricular remodelling by 2D ECHO
Time frame: six months
Twelve-month MACE or hospital admission for heart failure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
- Derived from this study: PubMed 23735474Parodi G, Valenti R, Migliorini A, Maehara A, Vergara R, Carrabba N, Mintz GS, Antoniucci D. Comparison of manual thrombus aspiration with rheolytic thrombectomy in acute myocardial infarction. Circ Cardiovasc Interv. 2013 Jun;6(3):224-30. doi: 10.1161/CIRCINTERVENTIONS.112.000172. Epub 2013 Jun 4.
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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.
David Antoniucci, MD principal investigator
Careggi Hospital, Division of Invasive Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manual Thrombectomy and AngioJet Rheolytic Thrombectomy (RT) System in people with ST-segment Elevation Myocardial Infarction and Thrombus, run by Careggi Hospital at 1 site in Italy.
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 8 inclusion and 14 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: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-thrombectomy thrombus burden as assessed by coronary OCT (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281033, which also lists 1 linked publication.
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 1 Aug 2013.