Bifurcation Lesion Analysis and STenting / BLAST

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Global multi-center, prospective, two-arm, randomized study. Patients will be randomized to either blinded or non-blinded IVUS assessment before the treatment of coronary bifurcation lesions. Treatment will be based either on grayscale and VH IVUS versus angiography alone.

After routine coronary angiogram, the physicians in the blinded arm of the study will only use the angiogram to guide the DES stenting procedure; the non-blinded arm will use the angiogram and IVUS grayscale and VH-IVUS to guide the procedure. In all patients, both pre- and post intervention, IVUS grayscale and VH-IVUS will be preformed on both branches of the bifurcation (blinded or non-blinded).

Conditions

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Coronary Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-blinded IVUS assessment

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

Nonblinded IVUS

Intervention Type DEVICE

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

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;

Blinded IVUS assessment

Intervention Type DEVICE

Only the angiogram is used for stent placement

Interventions

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Blinded IVUS assessment

Only the angiogram is used for stent placement

Intervention Type DEVICE

Nonblinded IVUS

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient must be greater than 18 years of age.
2. Patient is scheduled for coronary stenting of a bifurcation lesion in a native artery using Drug Eluting Stents (DES).
3. Patient must be willing and able to read and sign the informed consent document before planned coronary intervention.
4. 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.
5. Side branch lumen diameter min of \>2 mm by visual, angiographic estimate.
6. Patient must agree to be available for follow-up at 30 days, 1 and 2 years after procedure.
7. 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.

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Exclusion Criteria

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

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No