Use of Physiology to Evaluate Procedural Result After PCI CTO
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Netherlands
Radboud UMC
NOT_YET_RECRUITING
Nijmegen
Isala
RECRUITING
Zwolle
Contact Information
Primary
Maarten van Leeuwen, PhD
m.a.h.van.leeuwen@isala.nl
0031 38 424 2374
Time Frame
Start Date: 2021-07-21
Estimated Completion Date: 2026-06
Participants
Target number of participants: 200
Treatments
Other: Post-PCI intra-coronary physiological and OCT measurements
After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and OCT of the CTO vessel will be performed directly. OCT may als be performed during a staged procedure within 4 ± 2 weeks after the index procedure when clinically indicated.
Authors
Tom Meijers, Miguel Lemmert, Maarten Van Leeuwen
Related Therapeutic Areas
Sponsors
Collaborators: Abbott
Leads: Isala