NCT03106961

OCT and Scaffold Embedding After NC Balloon

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: St. Francis Hospital, New York · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Bioresorbable vascular scaffolds, OCT, non-compliant ballooning	Measure the effect of high-pressure, NC ballooning on scaffold embedding by OCT

Timeline

• Start date: 2017-03-30
• Primary completion: 2018-03-22
• Completion: 2018-06-30
• First posted: 2017-04-11
• Last updated: 2017-04-11

Locations

1 site across 1 country: United States