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CompariSon of Manual Aspiration With Rheolytic Thrombectomy in Patients Undergoing Primary PCI. The SMART-PCI Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01281033
First received: January 18, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
ST-segment Elevation Myocardial Infarction
Thrombus
 Procedure: Manual Thrombectomy
Procedure: AngioJet Rheolytic Thrombectomy (RT) System
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CompariSon of Manual Aspiration With Rheolytic Thrombectomy in Patients Undergoing Primary PCI. The SMART-PCI Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Careggi Hospital:

Primary Outcome Measures:
  • Post-thrombectomy thrombus burden as assessed by coronary OCT [ Time Frame: baseline ] [ Designated as safety issue: No ]
    OCT images analysis. The primary end-point of the study will be the number of thrombus containing vascular quadrants considering vascular slices.


Secondary Outcome Measures:
  • Angiographic thrombus grade after thrombectomy [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Angiographic markers of reperfusion:TIMI flow grade, TIMI myocardial blush. [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Procedural angiographic complications : distal embolization, no-reflow, perforation, dissection. [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Infarct size and microvascular obstruction measured by MRI at 3-7 days [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
  • Six-month MACE (death, reinfarction, TVR, stroke) [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • Six-month binary angiographic restenosis (> 50%) [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • Percent of malapposed struts at 6-month OCT follow-up [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Six-month left ventricular remodelling by 2D ECHO [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Twelve-month MACE or hospital admission for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: thrombus-aspiration group
In patients in the thrombus-aspiration group, the thrombus-aspiration is manually performed.
 Procedure: Manual Thrombectomy
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.
Other Name: manual aspiration
Experimental: AngioJet Rheolytic Thrombectomy
AngioJet Rheolytic Thrombectomy (RT) System consists of a drive unit console, disposable pump set, and disposable catheter.
 Procedure: AngioJet Rheolytic Thrombectomy (RT) System
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.
Other Names:
  • Mechanical Thrombectomy
  • AngioJet Rheolytic Thrombectomy (RT) System

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281033

Locations
Italy
Careggi Hospital
Florence, Italy, 50134
Sponsors and Collaborators
Careggi Hospital
Cardiovascular Research Foundation, New York
Investigators
Principal Investigator: David Antoniucci, MD Careggi Hospital, Division of Invasive Cardiology
  More Information

No publications provided

Responsible Party: David Antoniucci, MD, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01281033     History of Changes
Other Study ID Numbers: SMART-PCI
Study First Received: January 18, 2011
Last Updated: November 22, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Careggi Hospital:
primary PCI
ST-segment elevation myocardial infarction
thrombus aspiration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on May 23, 2013