Computed Tomography Coronary Angiography (CTCA) Prior to Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI) - a Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A Chronic Total Occlusion or CTO of a coronary artery is a an artery that has been blocked for \>/= 3 months. More than a decade ago, patients with such coronary artery blockage would have been sent for Coronary Artery Bypass Graft (CABG) surgery. Newer tools and techniques have facilitated the opening (angioplasty or percutaneous coronary intervention (PCI)) of such occluded arteries- however success is not 100% unlike in simple coronary blockages. Computed Tomography Coronary Angiography (CTCA) identifies the artery path and characteristics of the CTO including calcification - the latter many times is the reason for failure to cross the CTO. The investigators aim to conduct a feasibility study to assess the effectiveness of CTCA prior to CTO PCI by randomizing suitable CTO patients to CTCA or direct CTO PCI. 20 patients will be randomized 1:1 using the sealed envelope technique and compared for: Primary endpoint: CTO PCI success rate in CTCA arm versus no CTCA arm Secondary endpoints: i. Angina by the Seattle Angina Questionnaire (SAQ) at 6 months (range 0-100, lower score worse, higher scores better, based on 5 characteristics - severity, frequency, treatment satisfaction and quality of life scores). ii. Compare the number of patients who required a second CTO PCI procedure in the CTCA arm versus no CTCA arm iii. Procedural differences between the intervention CTCA arm versus no CTCA arm including: Health Economics: Cost saved per patient due to improved success and reduction in readmission or further procedure CTO PCI efficiency: Wire crossing time, Procedure time CTO PCI safety outcomes: Procedural complications (Ellis perforation, tamponade, acute kidney injury/contrast induced nephropathy, access site bleeding, donor vessel injury), Radiation: CTCA dose, CTO PCI dose, and combined CTCA and CTO PCI dose. Contrast: CTCA volume, CTO PCI volume, and combined CTCA and CTO PCI volume Change in CTO PCI strategy hierarchy as a result of the CTCA review Patients will have a telephonic follow up at 6 months to assess angina ( by the Seattle Angina Questionnaire)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years

• CTO with J-CTO score≥2

• Appropriate indication for CTO PCI

• Adequate CTCA images for analysis

Locations
Other Locations
United Kingdom
SWBH NHS Trust
RECRUITING
Birmingham
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2025-09
Participants
Target number of participants: 20
Treatments
Experimental: CTCA prior to CTO PCI
A diagnostic CTCA will be conducted prior to CTO PCI by at a level 2 CTCA trained operator. The results will be discussed with the CTO operator prior to the CTO PCI.
No_intervention: No CTCA prior to CTO PCI
Patients will be listed directly for the CTO PCI procedure without undergoing CTCA prior
Sponsors
Leads: Sandwell & West Birmingham Hospitals NHS Trust

This content was sourced from clinicaltrials.gov