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Optical Coherence Tomography Morphologic and Fractional Flow Reserve Assessment in Diabetes Mellitus Patients

NCT02989740 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2021-09-05

No results posted yet for this study

Summary

Title:

Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients COMBINE (OCT-FFR) Prospective Register

To study the natural evolution of patients with at least one intermediate angiographic but non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no TCFA as detected by OCT imaging and to compare these two groups of patients with each other as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on future MACE.

Conditions

Interventions

PROCEDURE

Optical Coherence Tomography

Patients aged ≥ 18 years bearing target lesions that fulfil the inclusion criteria and have undergone FFR and OCT imaging as per clinical practice will be enrolled in the study.

Sponsors & Collaborators

  • Isala

    collaborator OTHER

  • St. Jude Medical Nederland B.V.

    collaborator INDUSTRY

  • Diagram B.V.

    lead OTHER

Principal Investigators

  • E Kedhi, MD PhD · Erasmus Academical Hospital Brussels

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-26
Primary Completion
2020-06-30
Completion
2021-02-28

Countries

  • Netherlands

Study Locations

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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 NCT02989740 on ClinicalTrials.gov