NCT02316782

Bifurcation Lesion Analysis and STenting / BLAST

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 195 (actual)
• Sponsor: Volcano Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Coronary Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Blinded IVUS assessment	Only the angiogram is used for stent placement
DEVICE	Nonblinded IVUS	Angiogram, Grayscale IVUS and VH IVUS used for stent placement pre and post intervention

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-12-01
• Completion: 2013-12-01
• First posted: 2014-12-15
• Last updated: 2024-06-17

Locations

10 sites across 8 countries: United States, Denmark, France, Italy, Latvia, Netherlands, Poland, United Kingdom