Bifurcation Lesion Analysis and STenting / BLAST

NCT02316782 | Completed

• 1 other identifier: RSC-001
• Study Type: observational
• Target: 195
• Locations: 8 countries
• Sites: 10

Brief Summary

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.

Conditions

Coronary Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• IVUS with VH guidance leads to better post procedural outcomes when compared

  The primary objective of this randomized study is to demonstrate that pre-intervention IVUS can provide more accurate information on lesion characteristics than information derived from pre-procedural angiogram alone. This will be determined by full lesion coverage, no acute evidence of plaque protrusion or dissection at the stent edge, no evidence of stent underexpansion, no evidence of stent malapposition, or no significant side branch disease left behind.

  2 years

Study Arms (2)

Non-blinded IVUS assessment

The non-blinded arm will use the angiogram and IVUS grayscale and VH-IVUS to guide the procedure.

Device: Nonblinded IVUS

Blinded IVUS assessment

After routine coronary angiogram, the physicians in the blinded arm of the study will only use the angiogram to guide the DES stenting procedure;

Device: Blinded IVUS assessment

Interventions

Blinded IVUS assessment DEVICE

Only the angiogram is used for stent placement

Blinded IVUS assessment

Nonblinded IVUS DEVICE

Angiogram, Grayscale IVUS and VH IVUS used for stent placement pre and post intervention

Non-blinded IVUS assessment

Eligibility Criteria

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

Study Population

Per Protocol Population All patients who met all inclusion/exclusion criteria, completed the study intervention procedure as described in the protocol, and completed the 1-month follow-up. Intent to Treat Any subject randomized into the trial and there was an attempt to use the IVUS but either side branch was not IVUS'd pre and post intervention.

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).

Sponsors & Collaborators

• Volcano Corporation: lead

Study Sites (10)

Saint Luke's Hospital-Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Kardiologisk laboratorium/B-lab Skejby Sygehus

Aarhus, Denmark

Location

Clinique Saint Augustin

Bordeaux, France

Location

Hopital de la Cavale Blanche-CHU

Brest, France

Location

Nouvelles Cliniques Nantaises

Nantes, France

Location

Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista al Torino Departp Emodinamica Universitaria

Torino, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

CSK MSWiA w Warszawie

Warsaw, Poland

Location

St. Thomas Hospital Cardiothoracic Centre

London, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Thierry Lefevre, M.D.

  Institute Hospitalier J Cartier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: December 15, 2014
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2013
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

GB (1); DK (1); PL (1); LA (1); IT (1); NL (1); FR (3); US (1)