Use of Physiology to Evaluate Procedural Result After PCI CTO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO.

The main objective of the study is to evaluate both the value of post-PCI RFR and post-PCI FFR for detecting suboptimal stent result (SSR).

After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) of the CTO vessel will be performed. Additional OCT will be performed directly or during a staged procedure within 4 ± 2 weeks when indicated (i.e. high contrast use, procedural duration, major dissection or other safety reasons according to the operator).

When intra-coronary physiologic assessment or OCT is not possible at all, the patients will not be included in the study.

When the operator decides to optimize the stent result (post-dilation or additional stenting), based on the OCT and/or physiology, post-PCI RFR and FFR should be repeated. For patients undergoing a clinically indicated FFR of a remaining intermediate stenosis (angiographically 30-90%) in a non-CTO vessel or major side branch of the CTO vessel within 4 weeks after the index procedure, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) will be repeated in the CTO vessel for exploratory objectives

At 4 ± 2 weeks follow-up, the occurrence of cardiovascular events and clinical classification will be assessed for secondary objectives

Conditions

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Percutaneous Coronary Revascularisation Complex Coronary Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

post-PCI Pd/Pa

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Post-PCI RFR Post-PCI CFR Post-PCI IMR Post-PCI FFR Post-PCI OCT

Eligibility Criteria

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Inclusion Criteria

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