Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients (TROFI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01271361
First received: January 5, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.


Condition Intervention Phase
Coronary Artery Disease
Myocardial Infarction
STEMI
Procedure: primary PCI with thrombectomy
Procedure: primary PCI without thrombectomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study

Resource links provided by NLM:


Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • minimal flow area assessed by OFDI [ Time Frame: at baseline procedure (post-stenting) ] [ Designated as safety issue: No ]
    Flow area is defined as: (Stent area + incomplete stent apposition area) - (intraluminal defect area attached to the wall + intraluminal defect area free from the wall)


Secondary Outcome Measures:
  • normalised minimal flow area [ Time Frame: at baseline procedure (post stenting) ] [ Designated as safety issue: No ]
    defined as the ratio of minimal flow divided by stent area at the site of the minimal flow area

  • mean flow area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
  • intraluminal defect area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
  • mean stent area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
  • percent of malapposed struts [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
  • incomplete stent apposition (ISA) area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
  • percent of struts with coverage [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • healing index [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • tissues prolapse area/volume [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • procedure success [ Time Frame: at baseline procedure ] [ Designated as safety issue: No ]
    attainment of <30% residual stenosis of the target lesion and no in-hospital target vessel failure

  • target vessel failure [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
    defined as cardiac death, reinfarction in the territory of infarction related vessel (Q wave and non-Q wave), or clinically driven target vessel revascularization - and its individual components

  • all-cause mortality [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • cardiac death, non-cardiovascular death, vascular death [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • any myocardial (re)infarction [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • target vessel revascularization [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • stent thrombosis according to ARC definition [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • other serious adverse events (SAEs) [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: primary PCI with thrombectomy
thrombectomy before implantation of drug eluting stent
Procedure: primary PCI with thrombectomy
thrombectomy is performed before implantation of a drug eluting stent
Other Names:
  • Eliminate thrombectomy device
  • Nobori Biolimus A9 drug-eluting stent
Active Comparator: primary PCI without thrombectomy
implantation of a drug eluting stent without thrombectomy
Procedure: primary PCI without thrombectomy
no thrombectomy is performed before the implantation of a drug eluting stent
Other Name: Nobori Biolimus A9 drug-eluting stent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is at least 18 years of age.
  • Patients with a ST-elevation Myocardial Infarction documented in an ambulance or in a Cathlab with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min and having an angiographical visible stenosis (>30%) or TIMI≤ II in de-novo, native, previously unstented vessel.
  • The single vessel coronary artery disease.
  • Signed Informed Consent.
  • The patient understands and accepts clinical follow-up and OFDI controls.
  • Patients residence is in the area covered by hospital. Angiographic
  • Vessel size should match available Nobori stent sizes (<4.0 mm, and >2.0 mm by visual assessment).

Additional Inclusion criteria (applicable only for France)

  • Patients residence is in the area covered by hospital.
  • Patient is affiliated to social security or equivalent system.

Exclusion Criteria:

  • Pregnancy and women of child bearing potential (less than 50 years of age).
  • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast material.
  • Diameter Stenosis <30% in the target lesion.
  • The multi-vessel coronary artery disease (DS>50%).
  • Unprotected left main disease with a diameter stenosis of >30% by visual assessment.
  • Distal vessel occlusion.
  • Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter.
  • Fibrinolysis prior to PCI.
  • Known thrombocytopaenia (PLT< 100,000/mm3).
  • Contraindication to PCI, stenting, ASA, clopidogrel.
  • Active bleeding or coagulopathy or patients at chronic anticoagulation therapy.
  • Cardiogenic Shock.
  • Significant comorbidities precluding clinical follow-up (as judged by investigators).
  • Major planned surgery that requires discontinuation of dual antiplatelet therapy.
  • Proximal RCA stenosis (>30%) if the infarct-related artery is mid-RCA or distal-RCA.
  • People under judicial protection.
  • A patient who has congenital heart disease, severe cardiac valve disorder and/or myocardial disease (excluding status post MI).
  • Patient participating in other clinical research study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271361

Locations
Denmark
Aarhus University Hospital Skejby
Aarhus, Denmark, 8200
France
Clinique Pasteur
Toulouse, France, 31076
Germany
Universität Leipzig - Herzzentrum
Leipzig, Germany, 04289
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3000CA
Maastad Hospital
Rotterdam, Netherlands, 3015EA
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
Principal Investigator: Patrick W Serruys, MD Erasmus Medical Center, Rotterdam, Netherlands
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01271361     History of Changes
Other Study ID Numbers: T114E4
Study First Received: January 5, 2011
Last Updated: December 6, 2012
Health Authority: Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
France: Conseil National de l'Ordre des Médecins
France: French Data Protection Authority
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Terumo Europe N.V.:
thrombus aspiration
Drug-Eluting Stent
optical frequency domain imaging (OFDI)

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014