Status:
COMPLETED
The INFUSE - Anterior Myocardial Infarction (AMI) Study
Lead Sponsor:
Atrium Medical Corporation
Conditions:
Acute Anterior Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452 subjects enrolled in up to 50 US and European sites. Subjects who present with anterior ST-elevation myocar...
Detailed Description
The primary objective of the study is to demonstrate that among subjects undergoing primary PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy, the intracoronary in...
Eligibility Criteria
Inclusion
- Key
- The subject must be \>18 years of age;
- Subject is experiencing clinical symptoms consistent with AMI (e.g., chest pain, arm pain, etc.,) \>30 minutes duration and unresponsive to nitroglycerin;
- Anterior MI with ECG showing at least 1 mm of ST-segment elevation in 2 or more contiguous leads in V1-V4, or new (or presumably new) left bundle branch block;
- Anticipated symptom onset to balloon or aspiration time of ≤5 hours;
- The subject and his/her physician are willing to comply with specified follow-up evaluations;
- The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB)
- Infarct artery located in the proximal or mid left anterior descending coronary artery, with TIMI 0/1/2 flow at the time of initial diagnostic angiography (prior to wire passage);
- Based on coronary anatomy, PCI is indicated for revascularization;
- Only one epicardial coronary artery will be treated;
- Expected ability to deliver a ClearWay™ RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification).
- Key
Exclusion
- Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction \<40% by any prior measure or regional wall motion abnormalities);
- An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first twelve months post enrollment;
- Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the AMI;
- Subject has previously undergone an angioplasty or stenting procedure in the left anterior descending artery;
- Definite planned use of aspiration, atherectomy, thrombectomy and/or distal protection catheters prior to PTCA or stent implantation (other than in subjects randomized to thrombus aspiration);
- Any contraindication to undergo MRI imaging.
- Multivessel intervention required during the index procedure (subjects may be enrolled if treatment of more than one lesion in the LAD or its branches is required, however) (planned staged procedures are permitted with strong recommendation to be performed after 30-day clinical and MRI endpoints are completed);
- Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the ClearWay™ RX Infusion Catheter or the Export® Aspiration Catheter;
- Features are present highly unfavorable for PCI;
- Target lesion is present within a bypass graft conduit;
- MI is due to thrombosis within or adjacent to a previously implanted stent;
- Left ventriculography demonstrates severe mitral regurgitation or a VSD;
- Unprotected left main stenosis \>40% or that will require intervention
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT00976521
Start Date
September 1 2009
End Date
April 1 2013
Last Update
July 8 2013
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
2
Carolinas Medical Center-SHVI
Charlotte, North Carolina, United States, 28203
3
Moses Cone Vascular Center
Greensboro, North Carolina, United States, 27401
4
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822