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Completed

NCT Number: NCT02643940

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years of age
  • Stable angina / ischaemic symptoms
  • Evidence of viability and / or ischaemia in the chronic total occlusion (CTO) territory
  • Participant is willing and able to give informed consent for participation in the study
  • 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
  • Presence of minor to intermediate coronary stenosis (1-70 %) in the contralateral donor artery
  • Eligible for PCI to a chronic total occlusion (CTO)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Coronary pressure changes

    Time frame: 5 Minutes

    Changes in coronary pressure - derived measurements (resting Pd/Pa, iFR and FFR) in donor artery pre and post RCA CTO PCI

Secondary outcomes

  1. Population correlation

    Time frame: 5 minutes

    Correlation between coronary pressure---derived measurements in this population.

  2. Donor artery correlation

    Time frame: 5 minutes

    Correlation between collateral circulation function on coronary pressure - derived measurements in donor artery pre and post RCA CTO PCI.

  3. Cardiac MRI correlation

    Time frame: 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)

  4. Effects of stenosis severity (QCA)

    Time frame: 5 minutes

    Effects of stenosis severity (QCA) in donor artery on coronary pressure-derived measurements

  5. Collateral circulation characteristics

    Time frame: 5 minutes

    Influence of collateral circulation characteristics on coronary pressure-derived measurements

  6. Coronary pressure and jeopardy scores correlation

    Time frame: 5 minutes

    Correlation between coronary pressure-derived measurements in the donor artery and myocardial jeopardy scores in the donor artery

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: IMPACT-CTO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2015
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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