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OCT and Scaffold Embedding After NC Balloon

NCT03106961 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-04-11

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Bioresorbable vascular scaffolds, OCT, non-compliant ballooning

Measure the effect of high-pressure, NC ballooning on scaffold embedding by OCT

Sponsors & Collaborators

  • Akiko Maehara, MD

    collaborator UNKNOWN

  • St. Francis Hospital, New York

    lead OTHER

Principal Investigators

  • Richard A Shlofmitz, MD · St FrancisHospiral

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2018-03-22
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106961 on ClinicalTrials.gov