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

NCT01281033 | Completed Phase 4 DMC

• 1 other identifier: SMART-PCI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

ST-segment Elevation Myocardial Infarction; Thrombus

Keywords

primary PCI; ST-segment elevation myocardial infarction; thrombus aspiration

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (10)

• Angiographic thrombus grade after thrombectomy

  baseline

• ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG

  30 minutes

• Angiographic markers of reperfusion:TIMI flow grade, TIMI myocardial blush.

  baseline

• Procedural angiographic complications : distal embolization, no-reflow, perforation, dissection.

  baseline

• Infarct size and microvascular obstruction measured by MRI at 3-7 days

  3-7 days

Study Arms (2)

thrombus-aspiration group

ACTIVE COMPARATOR

In patients in the thrombus-aspiration group, the thrombus-aspiration is manually performed.

Procedure: Manual Thrombectomy

AngioJet Rheolytic Thrombectomy

EXPERIMENTAL

AngioJet Rheolytic Thrombectomy (RT) System consists of a drive unit console, disposable pump set, and disposable catheter.

Procedure: AngioJet Rheolytic Thrombectomy (RT) System

Interventions

Manual Thrombectomy PROCEDURE

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.

Also known as: manual aspiration

thrombus-aspiration group

AngioJet Rheolytic Thrombectomy (RT) System PROCEDURE

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.

Also known as: Mechanical Thrombectomy

AngioJet Rheolytic Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Target artery has a reference vessel diameter 2.5 mm on visual assessment at baseline angiography.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Careggi Hospital: lead
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (1)

Careggi Hospital

Florence, 50134, Italy

Location

Related Publications (1)

• 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.

  PMID: 23735474 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Thrombosis

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• David Antoniucci, MD

  Careggi Hospital, Division of Invasive Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 21, 2011
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

IT (1)