The Impact of Coronary Chronic Total Occlusion Percutaneo... | NCT03830853

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

NCT03830853

Sponsor

Mid and South Essex NHS Foundation Trust

Status

Completed

Last Update Posted

Dec 21, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Chronic Total Occlusion of Coronary Artery

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

Jan 23, 2015Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Jan 1, 2018Actual

First Submitted Date

Jan 22, 2019

First Submission Date that Met QC Criteria

Feb 4, 2019

First Posted Date

Feb 5, 2019Actual

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

Dec 21, 2021Actual

Name	Class
Brighton and Sussex University Hospitals NHS Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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.

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

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Successful CTO PCI achieved		Patients will have successful CTO PCI (chronic total occlusion percutaneous coronary intervention) followed by physiological and intracoronary imaging. These measurements will be repeated at a 3 month follow up angiogram procedure.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in coronary flow	change in coronary flow at baseline and follow up	3 months
Change in coronary resistance	change in coronary absolute resistance at baseline and follow up	3 months

Secondary Outcomes

Measure	Description	Time Frame
Change in coronary anatomy	To identify intracoronary anatomical features between baseline and follow up.	3 months
Change in exercise work load	Change in exercise work measured in METS (metabolic equivalents).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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 who have been selected for elective percutaneous coronary angioplasty (PCI) of their chronic total occlusion (CTO) as part of routine standard of care will be approached for the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Davies, MBBS, PhD	Basildon and Thurrock University Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Essex Cardiothoracic Centre		Basildon	Essex	S16 5NL	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided