The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology

Completed

• Conditions: Chronic Total Occlusion of Coronary Artery

• Registration Number: NCT03830853
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

Brief Summary

Following successful CTO PCI, a multitude of physiological and anatomical changes take place. Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term follow up of these features. It is not known whether changes in this level of physiology and anatomy in the context of CTO vessels correlate with each other, or with quality of life and exercise capacity.

This study aims to take physiological measurements of absolute coronary flow, resistance and pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators will relate these to each other and to the method of revascularisation, comparing changes in these groups at three months follow up.

QoL measurements, and exercise testing will be carried out to see if there is a relationship between physiological and anatomical changes with exercise capacity and quality of life.

Results from this study could shed light on optimisation of CTO PCI procedural and clinical outcomes.

Detailed Description

Following successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI), a multitude of physiological and anatomical changes take place. Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term follow up of these features. It is not known whether changes in this level of physiology and anatomy in the context of CTO vessels correlate with each other, or with quality of life and exercise capacity.

This study aims to take physiological measurements of absolute coronary flow, resistance and pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators will relate these to each other and to the method of revascularisation, comparing changes in these groups at three months follow up.

Quality of life measurements, and exercise testing will be carried out to see if there is a relationship between physiological and anatomical changes with exercise capacity and quality of life.

Results from this study could shed light on optimisation of CTO PCI procedural and clinical outcomes.

Study Timeline

• Study Start: 2015-01-23
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 years of age
• Presence of a coronary chronic total occlusion (CTO) scheduled for elective percutaneous coronary angioplasty (PCI)
• Evidence of viability in the CTO Territory

Exclusion Criteria

• < 18 year of age
• Unable to give informed consent
• Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis
• Unable to receive antiplatelets or periprocedural anticoagulation
• Contraindications to adenosine
• Any study lesion characteristic resulting in the expected inability to deliver FD-OCT catheter at the distal vessel post CTO PCI (e.g. moderate or severe vessel calcification or tortuosity)
• Pregnancy, planning pregnancy during study period, or breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in coronary flow	3 months	change in coronary flow at baseline and follow up
Change in coronary resistance	3 months	change in coronary absolute resistance at baseline and follow up

Secondary Outcome Measures

Name	Time	Method
Change in exercise work load	3 months	Change in exercise work measured in METS (metabolic equivalents).
Change in coronary anatomy	3 months	To identify intracoronary anatomical features between baseline and follow up.
Change in quality of life	3 months	change in quality measured by the validated Seattle angina seven question questionnaire from baseline to follow up. This is a scale based on 7 questions giving scores of 0-100 on physical limitation, angina, and quality of life, with the average of these scores giving a mean value also ranging from 0-100 of the overall summary score.
Change in coronary pressure measurements	3 months	change in fractional flow reserve (FFR) at baseline and follow up

Trial Locations

Locations (1)

The Essex Cardiothoracic Centre; 🇬🇧 Basildon, Essex, United Kingdom