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

Coronary Artery Disease Clinical Trial

— IMPACT-CTO  

Official title:

The Physiological IMPACT of Coronary Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI) on Coronary Pressure --Derived Measurements, Its Correlation in the Donor Vessel and the Influence of Collateral Circulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643940
• Other study ID #: B785
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: December 2021
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease

Locations

Country	Name	City	State
United Kingdom	The Essex Cardiothoracic Centre	Basildon	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Karamasis GV, Kalogeropoulos AS, Mohdnazri SR, Al-Janabi F, Jones R, Jagathesan R, Aggarwal RK, Clesham GJ, Tang KH, Kelly PA, Davies JR, Werner GS, Keeble TR. Serial Fractional Flow Reserve Measurements Post Coronary Chronic Total Occlusion Percutaneous — View Citation

Mohdnazri SR, Karamasis GV, Al-Janabi F, Cook CM, Hampton-Till J, Zhang J, Al-Lamee R, Dungu JN, Gedela S, Tang KH, Kelly PA, Davies JE, Davies JR, Keeble TR. The impact of coronary chronic total occlusion percutaneous coronary intervention upon donor ves — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary pressure changes	Changes in coronary pressure - derived measurements (resting Pd/Pa, iFR and FFR) in donor artery pre and post RCA CTO PCI	5 Minutes
Secondary	Population correlation	Correlation between coronary pressure---derived measurements in this population.	5 minutes
Secondary	Donor artery correlation	Correlation between collateral circulation function on coronary pressure - derived measurements in donor artery pre and post RCA CTO PCI.	5 minutes
Secondary	Cardiac MRI correlation	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)	5 minutes
Secondary	Effects of stenosis severity (QCA)	Effects of stenosis severity (QCA) in donor artery on coronary pressure-derived measurements	5 minutes
Secondary	Collateral circulation characteristics	Influence of collateral circulation characteristics on coronary pressure-derived measurements	5 minutes
Secondary	Coronary pressure and jeopardy scores correlation	Correlation between coronary pressure-derived measurements in the donor artery and myocardial jeopardy scores in the donor artery	5 minutes