Bifurcation Lesion Analysis and STenting / BLAST

Coronary Atherosclerosis Clinical Trial

— BLAST  

Official title:

Bifurcation Lesion Analysis and STenting / BLAST

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316782
• Other study ID #: RSC-001
• Status: Completed
• Phase: N/A
• First received: May 14, 2014
• Last updated: December 10, 2014
• Start date: October 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Volcano Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Intervention

Device:
• Blinded IVUS assessment
Only the angiogram is used for stent placement
• Nonblinded IVUS
Angiogram, Grayscale IVUS and VH IVUS used for stent placement pre and post intervention

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Volcano Corporation

Countries where clinical trial is conducted

United States,  Denmark,  France,  Italy,  Latvia,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No