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

ST-segment Elevation Myocardial Infarction Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281033
• Other study ID #: SMART-PCI
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2011
• Last updated: July 31, 2013
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction
• Thrombus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Careggi Hospital	Florence

Sponsors (2)

Lead Sponsor	Collaborator
Careggi Hospital	Cardiovascular Research Foundation, New York

Country where clinical trial is conducted

Italy, 

Outcome

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