RecruitingNot ApplicableNCT04780971

Use of Physiology to Evaluate Procedural Result After PCI CTO


Sponsor

Isala

Enrollment

200 participants

Start Date

Jul 21, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age 18 years and older.
  • Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment.
  • Possibility to perform physiologic measurements and OCT of sufficient quality.
  • Patients willing and capable to provide written informed consent.

Exclusion Criteria1

  • \) Contra-indication for adenosine.

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Interventions

DIAGNOSTIC_TESTpost-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.


Locations(2)

Radboud UMC

Nijmegen, Netherlands

Isala

Zwolle, Netherlands

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NCT04780971