The Physiological Impact of CTO PCI on Coronary Pressure Measurements and Correlation in Donor Vessel

Completed

• Conditions: Acute Coronary Syndrome; Coronary Artery Disease

• Registration Number: NCT02643940
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

Brief Summary

This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment options; medications, stents or potentially bypass surgery, for patients with Chronic Total Occlusion (CTO).

Detailed Description

The patients in this study are planned to have a Percutaneous Coronary Intervention (PCI) with recanalization of Chronic Total Occlusion (CTO) on clinical grounds alone.

This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment option. To date there is no data available on instantaneous wave free ratio (iFR) measurement (a pressure derived assessment of flow limitation) in patients with blocked arteries.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Age >18 years of age

2. Stable angina / ischaemic symptoms

3. Evidence of viability and / or ischaemia in the chronic total occlusion (CTO) territory

4. Participant is willing and able to give informed consent for participation in the study

5. Presence of a chronic total occlusion (CTO) in RCA:

   • Duration of the occlusion > 3 months;
   • Thrombolysis In Myocardial Infarction (TIMI) (50) coronary flow grade 0;
   • Spontaneously visible collaterals, Rentrop classification grade 1 or 2 or 3 from contralateral donor artery

6. Presence of minor to intermediate coronary stenosis (1-70 %) in the contralateral donor artery

7. Eligible for PCI to a chronic total occlusion (CTO)

Exclusion Criteria

1. Previous CABG with patent grafts to the interrogated donor artery
2. Left main stenosis of > 40 %
3. Presence of severe flow limiting stenosis in the contralateral donor artery (typically > 70 % stenosis)
4. Haemodynamic instability at the time of intervention (heart rate <40 beats per minute, systolic blood pressure <90mmHg), balloon pump)
5. Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
6. Contraindications to PCI
7. Severe hepatic or lung disease (chronic pulmonary obstructive disease)
8. Pregnancy
9. ACS within 48 hours of procedure
10. Severe valvular heart disease
11. Severe cardiomyopathy / Infiltrative heart disease
12. eGFR < 40

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary pressure changes	5 Minutes	Changes in coronary pressure - derived measurements (resting Pd/Pa, iFR and FFR) in donor artery pre and post RCA CTO PCI

Secondary Outcome Measures

Name	Time	Method
Effects of stenosis severity (QCA)	5 minutes	Effects of stenosis severity (QCA) in donor artery on coronary pressure-derived measurements
Population correlation	5 minutes	Correlation between coronary pressure---derived measurements in this population.
Coronary pressure and jeopardy scores correlation	5 minutes	Correlation between coronary pressure-derived measurements in the donor artery and myocardial jeopardy scores in the donor artery
Donor artery correlation	5 minutes	Correlation between collateral circulation function on coronary pressure - derived measurements in donor artery pre and post RCA CTO PCI.
Cardiac MRI correlation	5 minutes	Correlation between baseline coronary pressure - derived measurements in donor artery pre RCA CTO PCI, collateral circulation indices and baseline non-invasive functional assessment /Cardiac MRI (CMR)
Collateral circulation characteristics	5 minutes	Influence of collateral circulation characteristics on coronary pressure-derived measurements

Trial Locations

Locations (1)

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