NCT00976521

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 myocardial infarction (STEMI) and an occluded proximal or mid left anterior descending (LAD) with TIMI 0/1/2 flow will be eligible for randomization to one of the following arms:

  1. 1.Local infusion of abciximab following thrombus aspiration
  2. 2.Local infusion of abciximab and no thrombus aspiration
  3. 3.No local infusion and thrombus aspiration
  4. 4.No local infusion and no thrombus aspiration

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
6 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

July 8, 2013

Completed
Last Updated

July 8, 2013

Status Verified

May 1, 2013

Enrollment Period

2.4 years

First QC Date

September 11, 2009

Results QC Date

April 12, 2013

Last Update Submit

May 31, 2013

Conditions

Acute Anterior Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion

    The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.

    30 Days Post Index Procedure

Secondary Outcomes (1)

  • Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration

    30 Days

Study Arms (4)

Local infusion, thrombus aspiration

EXPERIMENTAL

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.

Drug: Abciximab local infusionProcedure: Thrombus aspiration

Local infusion, no aspiration

EXPERIMENTAL

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no aspiration

Drug: Abciximab local infusion

No local infusion, thrombus aspiration

ACTIVE COMPARATOR

No local infusion of abciximab, thrombus aspiration.

Other: No local infusionProcedure: Thrombus aspiration

No local infusion, no aspiration

ACTIVE COMPARATOR

No local infusion abciximab and no thrombus aspiration

Other: No local infusion

Interventions

Abciximab local infusionDRUG

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

Local infusion, no aspirationLocal infusion, thrombus aspiration
No local infusionOTHER

Intervention without local infusion

No local infusion, no aspirationNo local infusion, thrombus aspiration
Thrombus aspirationPROCEDURE

Thrombus aspiration

Local infusion, thrombus aspirationNo local infusion, thrombus aspiration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Carolinas Medical Center-SHVI

Charlotte, North Carolina, 28203, United States

Location

Moses Cone Vascular Center

Greensboro, North Carolina, 27401, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Harrisburg Hospital/ Pinnacle Health

Harrisburg, Pennsylvania, 17110, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States

Location

Landeskrankenhaus Bruck/Mur

Bruck/Mur, Austria, 8600, Austria

Location

Landeskrankenhaus Graz West

Graz, Austria, 8020, Austria

Location

Univ. Klinik für Innere Medizin III Innsbruck

Innsbruck, Austria, 6020, Austria

Location

Univ. Klinik für Innere Medizin II

Vienna, Austria, 1090, Austria

Location

Landeskrankenhaus Braunau/Simbach

Braunau am Inn, 5280, Austria

Location

Universitätsmedizin Mannheim - I. Medizinische Klinik

Mannheim, Germany, 68167, Germany

Location

Klinikum der Universität Regensburg

Regensburg, Germany, 93053, Germany

Location

Charite- University Medicine Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Klinikum Villingen Kardiologie

Darmstadt, 64283, Germany

Location

Facharzt fur Innere Medizin/Kardiologie

Ludwigshafen, D-67063, Germany

Location

Universtitätsklinikuim Ulm

Ulm, 89081, Germany

Location

Ziekenhuis Rijnstate

Arnhem, NL, 6815 AD, Netherlands

Location

Catharina Hospital Eindhoven

Eindhoven, 5623 EJ, Netherlands

Location

Isala Klinieken, Locatie de Weezenlanden

Zwolle, 8011 JW, Netherlands

Location

Polsko - Amerykańskie Kliniki Serca II Oddział Kardiologiczny American Heart of Poland Sp. z o.o.

Bielsko-Biala, Poland, 43316, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie, Centrum Interwencyjne Leczenia Chorób Serca i Naczyń

Krakow, Poland, 31102, Poland

Location

SPZOZ Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Hemodynamiki i Angiografii

Krakow, Poland, 31501, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Pracownia Hemodynamiki I Katedry i Kliniki Kardiologii

Warsaw, Poland, 2097, Poland

Location

Instytut Kardiologii im. Prymasa Tysiąclecia Kardynała Stefana Wyszyńskiego,I Samodzielna Pracownia Hemodynamiki

Warsaw, Poland, 4628, Poland

Location

Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

Krakow, 30693, Poland

Location

Pracownia Hemodynamiki Oddziału Kardiologicznego Wojewódzkiego Centrum Medycyny w Opolu

Opole, 45418, Poland

Location

Centrum Kardiologii Inwazyjnej GVM Carint

Oświęcim, 32600, Poland

Location

University Hospitals of Leicester - Glenfield Hospital

Leicester, U.k., LE3 9QP, United Kingdom

Location

King's College Hospital

London, U.k., SE5 9RS, United Kingdom

Location

Manchester Royal Infirmary

Manchester, U.k., M13 9WL, United Kingdom

Location

Wythenshawe Hospital

Manchester, U.k., M23 9LT, United Kingdom

Location

Southampton University Hospital

Southampton, U.k., SO16 6UD, United Kingdom

Location

Royal Victoria Hospital, Belfast Trust

Belfast, BT12 6BA, United Kingdom

Location

Bristol Heart Institute

Bristol, BS2 8HW, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (8)

  • Giustino G, Redfors B, Brener SJ, Kirtane AJ, Genereux P, Maehara A, Dudek D, Neunteufl T, Metzger DC, Crowley A, Mehran R, Gibson CM, Stone GW. Correlates and prognostic impact of new-onset heart failure after ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention: insights from the INFUSE-AMI trial. Eur Heart J Acute Cardiovasc Care. 2018 Jun;7(4):339-347. doi: 10.1177/2048872617719649. Epub 2017 Aug 22.

    PMID: 28828881DERIVED

  • Tomey MI, Mehran R, Brener SJ, Maehara A, Witzenbichler B, Dizon JM, El-Omar M, Xu K, Gibson CM, Stone GW. Sex, adverse cardiac events, and infarct size in anterior myocardial infarction: an analysis of intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction (INFUSE-AMI). Am Heart J. 2015 Jan;169(1):86-93. doi: 10.1016/j.ahj.2014.06.019. Epub 2014 Jul 3.

    PMID: 25497252DERIVED

  • Guerchicoff A, Brener SJ, Maehara A, Witzenbichler B, Fahy M, Xu K, Gersh BJ, Mehran R, Gibson CM, Stone GW. Impact of delay to reperfusion on reperfusion success, infarct size, and clinical outcomes in patients with ST-segment elevation myocardial infarction: the INFUSE-AMI Trial (INFUSE-Anterior Myocardial Infarction). JACC Cardiovasc Interv. 2014 Jul;7(7):733-40. doi: 10.1016/j.jcin.2014.01.166.

    PMID: 25060015DERIVED

  • Stone GW, Witzenbichler B, Godlewski J, Dambrink JH, Ochala A, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Dizon JM, Wolff SD, Brener SJ, Mehran R, Maehara A, Gibson CM. Intralesional abciximab and thrombus aspiration in patients with large anterior myocardial infarction: one-year results from the INFUSE-AMI trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):527-34. doi: 10.1161/CIRCINTERVENTIONS.113.000644. Epub 2013 Oct 1.

    PMID: 24084626DERIVED

  • Brener SJ, Maehara A, Dizon JM, Fahy M, Witzenbichler B, Parise H, El-Omar M, Dambrink JH, Mehran R, Oldroyd K, Gibson CM, Stone GW. Relationship between myocardial reperfusion, infarct size, and mortality: the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial. JACC Cardiovasc Interv. 2013 Jul;6(7):718-24. doi: 10.1016/j.jcin.2013.03.013.

    PMID: 23866184DERIVED

  • Brener SJ, Witzenbichler B, Maehara A, Dizon J, Fahy M, El-Omar M, Dambrink JH, Genereux P, Mehran R, Oldroyd K, Parise H, Gibson CM, Stone GW. Infarct size and mortality in patients with proximal versus mid left anterior descending artery occlusion: the Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction (INFUSE-AMI) trial. Am Heart J. 2013 Jul;166(1):64-70. doi: 10.1016/j.ahj.2013.03.029. Epub 2013 Apr 30.

    PMID: 23816023DERIVED

  • Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012 May 2;307(17):1817-26. doi: 10.1001/jama.2012.421. Epub 2012 Mar 25.

    PMID: 22447888DERIVED

  • Gibson CM, Maehara A, Lansky AJ, Wohrle J, Stuckey T, Dave R, Cox D, Grines C, Dudek D, Steg G, Parise H, Wolff SD, Cristea E, Stone GW. Rationale and design of the INFUSE-AMI study: A 2 x 2 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. Am Heart J. 2011 Mar;161(3):478-486.e7. doi: 10.1016/j.ahj.2010.10.006. Epub 2011 Jan 28.

    PMID: 21392601DERIVED

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Leah Hollins, Director of Clinical Affairs
Organization
Atrium Medical Corporation
lhollins@atriummed.com
603-880-1433

Study Officials

  • Greg W Stone, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2012

Study Completion

April 1, 2013

Last Updated

July 8, 2013

Results First Posted

July 8, 2013

Record last verified: 2013-05

Locations

DE(6)NL(3)US(7)PL(8)GB(9)AU(5)