The Physiological Impact of CTO PCI on Coronary Pressure... | NCT02643940

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

NCT02643940

Sponsor

Mid and South Essex NHS Foundation Trust

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome
Coronary Artery Disease

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

May 31, 2018Actual

Completion Date

May 31, 2018Actual

First Submitted Date

Dec 22, 2015

First Submission Date that Met QC Criteria

Dec 30, 2015

First Posted Date

Dec 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2021

Last Update Posted Date

Jan 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Population correlation	Correlation between coronary pressure---derived measurements in this population.	5 minutes
Donor artery correlation	Correlation between collateral circulation function on coronary pressure - derived measurements in donor artery pre and post RCA CTO PCI.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for a PCI CTO

Sampling Method

Probability Sample

Name	Affiliation	Role
Thomas Keeble, MBBS MRCP	The Essex Cardiothoracic Centre	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Essex Cardiothoracic Centre		Basildon	Essex	SS16 5NL	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30571203	Result	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 Coronary Intervention. Circ Cardiovasc Interv. 2018 Nov;11(11):e006941. doi: 10.1161/CIRCINTERVENTIONS.118.006941.
29569332

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D054058	Acute Coronary Syndrome
D003324	Coronary Artery Disease