MedTrace Logo

Use of Physiology to Evaluate Procedural Result After PCI CTO

NCT04780971 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-02-19

No results posted yet for this study

Summary

ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery.

The main objective of the study is to assess the predictive value of post-PCI resting full-cycle ratio (RFR) and fractional flow reserve (FFR) with regard to Fractional flow reserve (SSR) in CTO patients.

Conditions

  • Percutaneous Coronary Revascularisation
  • Complex Coronary Lesion

Interventions

DIAGNOSTIC_TEST

post-PCI Pd/Pa

After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and subsequent OCT of the CTO vessel will be performed. OCT may also be performed during a staged procedure when clinically indicated.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Isala

    lead OTHER

Principal Investigators

  • Maarten Van Leeuwen, PhD · Isala Zwolle

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

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 NCT04780971 on ClinicalTrials.gov