NCT00766740

Brief Summary

Available data from randomized trials on thrombectomy in patients with ST-elevation myocardial infarction have shown favourable trends on myocardial reperfusion. Better myocardial reperfusion may translate in better late clinical outcome. However, only few data are available on the impact of thrombectomy on long term clinical outcome. Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the long-term clinical outcome in STEMI patients randomized to percutaneous coronary intervention with or without thrombectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,686

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

9 months

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Acute Myocardial Infarction

Keywords

ST elevation myocardial infarctionthrombectomyprimary PCI

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    one year

Secondary Outcomes (3)

  • Major adverse coronary events (MACE: death + MI (myocardial infarction) + TLR (target lesion revascularization)

    one year

  • Myocardial infarction

    one year

  • Death + myocardial infarction

    one year

Study Arms (2)

1

ACTIVE COMPARATOR

thrombectomy

Device: thrombectomy devices

2

ACTIVE COMPARATOR

Standard PCI

Device: angioplasty

Interventions

thrombectomy devicesDEVICE

mechanical or manual devices able to remove thrombus from the coronary arteries.

Also known as: DIVER CE, PRONTO, EXPORT, X-SIZER, TVAC, RESCUE, ANGIO-JET
1
angioplastyDEVICE

percutaneous coronary angioplasty with use of balloon catheters and bare metal stents or drug eluting stents.

2

Eligibility Criteria

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

You may qualify if:

  • Comparison of PCI with Thrombectomy with Standard PCI in patients with STEMI
  • Randomized treatment allocation

You may not qualify if:

  • Equivocal treatment allocation process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (2)

  • Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet 2008; 371(9628):1915-20. Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, Sciagra R. Comparison of rheolitic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention of acute myocardial infarction. Am J Cardiol 2004,93:1033-35. Dudek D, Mielecki W, Legutko J, Chyrchel M, Sorysz D, Bartus S, Rzeszutko L, Dubiel JS. Percutaneous thrombectomy with the RESCUE system in acute myocardial infartion. Kardiol Pol 2004;61:523-33. Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 ;46(2):371-6. Lefevre T, Garcia E, Reimers B, Lang I, di Mario C, Colombo A, Neumann FJ, Chavarri MV, Brunel P, Grube E, Thomas M, Glatt B, Ludwig J; X AMINE ST Investigators. X-sizer for thrombectomy in acute myocardial infarction improves ST-segment resolution: results of the X-sizer in AMI for negligible embolization and optimal ST resolution (X AMINE ST) trial. J Am Coll Cardiol 2005;46:246-52. Noel B, Morice MC, Lefevre T et al. Thrombus aspiration in acute ST-elevation myocardial infarction: a randomized controlled trial. Circulation 2005; 112 (Suppl. II): 519. Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalò G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol 2006 17;48:1552-9. Ikari Y, Kawano S, Sakurada M, et al. Thrombus aspiration prior to coronary intervention improves myocardial microcirculation in patients with ST elevation acute myocardial infarction, the VAMPIRE Study. Circulation 2005;112 [Suppl., abstr]. Kaltoft A, Bottcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M, Kristensen J, Thuesen L, Krusell LR, Kristensen SD, Andersen HR, Lassen JF, Rasmussen K, Rehling M, Nielsen TT, Botker HE. Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation 2006;114:40-7. De Luca L, Sardella G, Davidson CJ, De Persio G, Beraldi M, Tommasone T, Mancone M,Nguyen BL, Agati L, Gheorghiade M, Fedele F. Impact of intracoronary aspiration thrombectomy during primary angioplasty on left ventricular remodelling in patients with anterior ST elevation myocardial infarction. Heart 2006;92:951-7. Svilaas T, Vlaar PJ, van der Horst IC et al. Thrombus Aspiration during Primary Percutaneous Coronary Intervention. N Engl J Med 2008;358: 557-67. Dudek D et al. Polish-Italian-Hungarian Randomized ThrombEctomy Trial. PHIRATE trial; Expert slide presentation from Late Breaking Clinical Trials, TCT 2007. Sardella G et al. Impact of thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI. (EXPIRA Trial); Expert slide presentation from Late Breaking Clinical Trials, TCT 2007. Chevalier B. Export Study; Expert slide presentation from Late Breaking Clinical Trials, TCT 2007.

    BACKGROUND

  • Burzotta F, De Vita M, Gu YL, Isshiki T, Lefevre T, Kaltoft A, Dudek D, Sardella G, Orrego PS, Antoniucci D, De Luca L, Biondi-Zoccai GG, Crea F, Zijlstra F. Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials. Eur Heart J. 2009 Sep;30(18):2193-203. doi: 10.1093/eurheartj/ehp348. Epub 2009 Sep 2.

    PMID: 19726437DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Francesco Burzotta, MD, PhD

    Catholic University of Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

IT(1)