A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction - INFUSE AMI

• Conditions: The study population will consist of up to 452 male and female subjects with anterior STEMI and occluded proximal or mid LAD with TIMI 0/1 flow with indication for primary PCI.; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10000904Term: Acute myocardial infarction, of other anterior wall

• Registration Number: EUCTR2009-013425-42-DE
• Lead Sponsor: Atrium Medical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

1. The subject must be = 18 years of age;
2. Subject is experiencing clinical symptoms consistent with AMI (e.g., chest pain, arm pain, etc.,) >30 minutes duration and unresponsive to nitroglycerin;
3. 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;
4. Anticipated symptom onset to balloon or aspiration time of = 5 hours;
5. The subject and his/her physician are willing to comply with specified follow-up evaluations;
6. 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).
7. Infarct artery located in the proximal or mid left anterior descending coronary artery, with TIMI 0/1 flow at the time of initial diagnostic angiography (prior to wire passage);
8. Based on coronary anatomy, PCI is indicated for revascularization;
9. Only one epicardial coronary artery will be treated; 10. Expected ability to deliver a ClearWay™ RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
2. Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction <40% by any prior measure or regional wall motion abnormalities);
3. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first twelve months post enrollment;
4. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the AMI;
5. Subject has previously undergone an angioplasty or stenting procedure in the left anterior descending artery;
6. 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);
7. Any contraindication to undergo MRI imaging.
8. Impaired renal function;
9. Known platelet count <100,000 cells/mm³ or >700,000 cells/mm³ or a Hgb <10g/dL;
10. Intended intracoronary infusion of supersaturated oxygen;
11. Subject has active bleeding or a history of bleeding diathesis or coagulopathy or refusal to receive blood transfusions if necessary;
12. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
13. Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
14. Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
15. Subject has received any organ transplant or is on a waiting list for any organ transplant;
16. Subject has other medical illness that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy of less than one year;
17. Subject has a known hypersensitivity or contraindication to abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine or prasugrel;
18. Subject has a known hypersensitivity or allergy to stainless steel, nickel, cobalt chromium, nitinol, titanium, and/or contrast media which cannot be effectively pre-medicated with steroids and diphenhydramine (e.g., rash).
19. Prior administration of thrombolytic therapy, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Subjects receiving prior unfractionated heparin may be enrolled;
20. Current use of coumadin;
21. Subjects presenting with cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergency IABP for hypotension treatment) or cardiopulmonary resuscitation prior to randomization;
22. Any significant medical condition which in the Investigator's opinion may interfere with the subject?s optimal participation in the study;
23. Currently participating in another investigational drug or device study, which has not completed the primary endpoint follow-up period;
24. Previous enrollment in this study.
25. Coronary anatomy such that coronary artery bypass graft surgery will possibly be required within 30 days;
26. Multivessel intervention required during the index procedure;
27. 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;
28. Features are present highly unfavorable for PCI;
29. Target lesion is present within a bypass graft conduit;
30. MI is

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified