OCT and Scaffold Embedding After NC Balloon

Coronary Artery Disease Clinical Trial

Official title: An Optical Coherence Tomography Evaluation of the Effects of High-Pressure, Non-compliant Ballooning on Scaffold Embedding

Status Recruiting

Clinical Trial Summary

This study is a single-center, prospective, observational study designed to subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions.

Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.

Clinical Trial Description

This study is a single-center, prospective, observational study designed to enroll 50 subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Consented subjects are to undergo PCI and have a lesion without angiographic calcification.

Eligible subjects who meet inclusion and exclusion criteria for BVS scaffold implant will have a BVS-specific implantation protocol with high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. Because the scaffold is compliant, a perfectly embedded scaffold is sometimes observed in a lesion with soft plaque, resulting in a smaller intra-luminal scaffold volume that may reduce the event rate. Enrolled subjects will have OCT ( optical coherence tomography ) pre and post BVS implantation to assess the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation (using the moderate pressure of 12 atm) to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT03106961
• Study type: Observational
• Source: St. Francis Hospital, New York
• Contact: Ricahrd A Shlofmitz, MD
• Phone: 516 390-9640
• Email: richard.shlofmitz@chsli.org
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2017
• Completion date: June 30, 2018