Bifurcation Lesion Analysis and STenting / BLAST

Completed

Conditions studied: Coronary Atherosclerosis

In brief

The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram alone. Additionally, this study is to determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term procedural outcome vs. bifurcation stenting with only angiographic guidance in native coronary arteries.

Key facts

Study ID

NCT02316782

Run by

Volcano Corporation

People needed

195

Starts

2008-10-01

Expected to finish

2013-12-01

Last updated by the study team

2024-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be greater than 18 years of age.
• Patient is scheduled for coronary stenting of a bifurcation lesion in a native artery using Drug Eluting Stents (DES).
• Patient must be willing and able to read and sign the informed consent document before planned coronary intervention.
• If the patient is female and of child bearing potential, a pregnancy test (serum HcG or urine dip stick) is negative within 7 days of the procedure.
• Side branch lumen diameter min of >2 mm by visual, angiographic estimate.
• Patient must agree to be available for follow-up at 30 days, 1 and 2 years after procedure.
• Other significant lesions in different vessels should be treated successfully (residual stenosis < 30%, normal TIMI flow, no EKG modification) before treating the index bifurcation lesion.

You may not qualify if…

• The patient experiences significant hepatic disease, renal disease, lung disease and/or malignant disease with unfavorable prognosis.
• Any contraindications for IVUS interrogation as determined by the investigator including sever vessel tortuosity and severe calcification by angiogram.
• Side branch lumen diameter < 2 mm by visual, angiographic estimate.
• The patient suffered a cerebrovascular accident within the past 6 months and has residual effects from the event.
• The patient suffered significant (as determined by the Investigator) gastrointestinal bleeding within the past 3 months.
• The most recent white blood cell count less than 3,000 cell/mm3 or the number of platelet is less than 100,000 cell/mm3.
• The patient has contraindication to antithrombotic regimen or anticoagulation therapy.
• Any other patients who are judged by principal Investigator to be inappropriate for participation in the trial.
• Existing hemorrhagic disease or coagulation problems creating inability to obtain homeostasis at entry site.
• The patient has history of or known reaction or sensitivity to contrast agent and is unable to be premedicated.
• Hemodynamic instability at the time of intervention.
• Severe chronic renal insufficiency (plasma/ serum creatinine > 2.5mg/dl) at the time of intervention, except for patients on dialysis.
• The lesion is 0.0.1. (Medina classification).
• The bifurcation lesion involves an anastamosis site from previous a coronary artery bypass surgery.
• Acute MI or recent MI with CPK > 3 times the normal value prior to intervention (during index hospitalization).
• Other significant lesion in the same vessel.
• Other lesion in a different vessel not successfully treated

Where it is running

• Saint Luke's Hospital-Mid America Heart Institute — Kansas City, Missouri, United States
• Kardiologisk laboratorium/B-lab Skejby Sygehus — Aarhus, Denmark
• Clinique Saint Augustin — Bordeaux, France
• Hopital de la Cavale Blanche-CHU — Brest, France
• Nouvelles Cliniques Nantaises — Nantes, France
• Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista al Torino Departp Emodinamica Universitaria — Torino, Italy
• Pauls Stradins Clinical University Hospital — Riga, Latvia
• Medisch Spectrum Twente — Enschede, Netherlands
• CSK MSWiA w Warszawie — Warsaw, Poland
• St. Thomas Hospital Cardiothoracic Centre — London, United Kingdom

Full record on ClinicalTrials.gov

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