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

NCT01271361 | Completed Phase 1 DMC

• 1 other identifier: T114E4
• Study Type: interventional
• Target: 140
• Locations: 4 countries
• Sites: 5

Brief Summary

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.

Conditions

Coronary Artery Disease; Myocardial Infarction; STEMI

Keywords

thrombus aspiration; Drug-Eluting Stent; optical frequency domain imaging (OFDI)

Outcome Measures

Primary Outcomes (1)

• minimal flow area assessed by OFDI

  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)

  at baseline procedure (post-stenting)

Secondary Outcomes (17)

• normalised minimal flow area

  at baseline procedure (post stenting)

• mean flow area/volume

  at baseline procedure (post stenting) and at 6 months

• intraluminal defect area/volume

  at baseline procedure (post stenting) and at 6 months

• mean stent area/volume

  at baseline procedure (post stenting) and at 6 months

• percent of malapposed struts

  at baseline procedure (post stenting) and at 6 months

Study Arms (2)

primary PCI with thrombectomy

EXPERIMENTAL

thrombectomy before implantation of drug eluting stent

Procedure: primary PCI with thrombectomy

primary PCI without thrombectomy

ACTIVE COMPARATOR

implantation of a drug eluting stent without thrombectomy

Procedure: primary PCI without thrombectomy

Interventions

primary PCI with thrombectomy PROCEDURE

thrombectomy is performed before implantation of a drug eluting stent

Also known as: Eliminate thrombectomy device, Nobori Biolimus A9 drug-eluting stent

primary PCI with thrombectomy

primary PCI without thrombectomy PROCEDURE

no thrombectomy is performed before the implantation of a drug eluting stent

Also known as: Nobori Biolimus A9 drug-eluting stent

primary PCI without thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (5)

Aarhus University Hospital Skejby

Aarhus, 8200, Denmark

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Universität Leipzig - Herzzentrum

Leipzig, 04289, Germany

Location

Erasmus Medical Center

Rotterdam, 3000CA, Netherlands

Location

Maastad Hospital

Rotterdam, 3015EA, Netherlands

Location

Related Publications (26)

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MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Patrick W Serruys, MD

  Erasmus Medical Center, Rotterdam, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

NL (2); DK (1); DE (1); FR (1)