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RecruitingNCT06414551Updated Aug 30, 2024

Calcification on CTCA of a CTO and PCI Outcomes

An observational study in Chronic Total Occlusion of Coronary Artery, Calcification and Computed Tomography Angiography, sponsored by Sandwell & West Birmingham Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-30.

Sponsored by Sandwell & West Birmingham Hospitals NHS Trust · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

A chronic total occlusion (CTO) is present in 15-20% of patients who are referred for invasive coronary angiography. CTO Percutaneous Coronary Intervention (PCI) procedure success rates have increased over the years and can be as high as 90% when performed by high-volume CTO operators.Procedurally, excess calcification in the CTO anatomy is one factor which makes it difficult to complete the procedure or obtain ideal stent expansion. Excess calcification is best identified by Computed Tomography Coronary Angiography (CTCA) rather than invasive angiography.

The investigators plan to retrospectively evaluate CTCA in patients who underwent CTO PCI and correlate calcification characteristics with CTO PCI outcomes and tools utilised for calcium modification.

Read the detailed description

Cohort: All coronary CTO patients who underwent a PCI attempt and also underwent CTCA at our centre in the last 5 years.

Method of identifying and consenting patients: Screening of our local database to identify suitable patients who fulfil the inclusion/exclusion criteria. These patients will be telephoned and the consent form and participant information sheet will be maile dot them along with a self addressed stamped envelope.On receipt of the consent form, we will countersign it and return a copy to the patient. Consented patients' images and reports of the CTCA and CTO PCI will be reviewed.

Characteristics of calcification in the CTO on the CTCA will be evaluated including site, density and quantity of calcification. This will be correlated with CTO PCI outcomes of success and failure. Also this will be correlated with use of calcium modification tools for the CTO PCI.

  • Baseline and demographic as well as procedural data will be compared with CTO PCI outcomes and presence/characteristics of calcification.
  • Characteristics of calcification in the CTO assessed will include: site, density in Hounsfield units and quantity.
  • Site of calcification (proximal, body or distal) will be correlated with the CTO PCI outcome by chi square analysis.
  • Calcium density (in Hounsfield Units) on the CTCA will be correlated with successful versus failed CTO PCI by ROC curve analysis.
  • Quantity of calcification will be assessed as a percentage of the cross section of the CTO body (as \<50%, 50-75% and 75-100%) and correlated with CTO PCI success by contingency analysis.
  • Use of calcium modification tools will be correlated with CTO PCI outcome (success or failure) and density of calcification on CTCA (ROC curve and ANOVA).
  • Categorical variables will be compared by the chi square or Fisher's test and continuous variables will be compared by the Mann Whitney U test. In addition, based on CTO PCI outcome of success or failure, patients will be compared for demographics and procedural variables.
  • Categorical variables will be presented as percentage and compared with the chi square or Fisher's test
  • Continuous variables will be presented as median (range) and compared with student's t-test or Mann Whitney test.
02

Conditions studied

  • Chronic Total Occlusion of Coronary Artery
  • Calcification
  • Computed Tomography Angiography

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Keywords

  • CTCA
  • CTO
03

In context

Calcinosis

91 studies on the registry are indexed under Calcinosis; 19 are open to participants now.

This study's planned enrollment of 100 is below the median of 180 across 31 observational studies indexed under Calcinosis.

Browse Calcinosis studies →

Lead sponsor

Sandwell & West Birmingham Hospitals NHS Trust is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with coronary CTO who underwent attempt at PCI and also underwent CTCA

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients meeting all the below criteria will be included

    • ≥18 years
    • Previous CTO PCI attempt in the last 5 years
    • Undergone CTCA either pre or post CTO PCI
    • Adequate CTCA images for analysis

Exclusion criteria

Exclusion Criteria:

  • Patients meeting any of the following criteria will be excluded

    • \<18 years of age
    • Did not undergo CTCA
    • Inadequate/degraded CTCA images
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • CTO patients who underwent attempted PCI

    Patients with coronary CTO who underwent attempt at PCI and also underwent a CTCA

06

What researchers measure

Primary outcomes

  1. Correlation of characteristics of calcification with CTO PCI outcome (success or failure)

    Success or failure

    Time frame: up to 24 hours

Secondary outcomes

  1. Utility of calcium modifying tools for the CTO PCI procedure and correlation with severity of calcification

    Percentage of patients in whom any calcium modifying tool was used and the corelation of this with the severity of calcification.

    Time frame: up to 24 hours

07

Study locations

1 of 1 sites recruiting
  • Birmingham City Hospital, Sandwell and West Birmingham NHS Trust
    Birmingham, West Midlands B18 7QH, United Kingdom
    Recruiting
08

References and documents

Publications

  • Tajti P, Brilakis ES. Chronic Total Occlusion Percutaneous Coronary Intervention: Evidence and Controversies. J Am Heart Assoc. 2018 Jan 12;7(2):e006732. doi: 10.1161/JAHA.117.006732. No abstract available. PubMed 29330258 ↗
  • Patel VG, Brayton KM, Tamayo A, Mogabgab O, Michael TT, Lo N, Alomar M, Shorrock D, Cipher D, Abdullah S, Banerjee S, Brilakis ES. Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv. 2013 Feb;6(2):128-36. doi: 10.1016/j.jcin.2012.10.011. Epub 2013 Jan 23. PubMed 23352817 ↗
  • Sharma V, Jadhav ST, Harcombe AA, Kelly PA, Mozid A, Bagnall A, Richardson J, Egred M, McEntegart M, Shaukat A, Oldroyd K, Vishwanathan G, Rana O, Talwar S, McPherson M, Strange JW, Hanratty CG, Walsh SJ, Spratt JC, Smith WH. Impact of proctoring on success rates for percutaneous revascularisation of coronary chronic total occlusions. Open Heart. 2015 Mar 28;2(1):e000228. doi: 10.1136/openhrt-2014-000228. eCollection 2015. PubMed 25852949 ↗
  • Simon W. The Consistent CTO Study. 2018.
  • Gada H, Whitlow PL, Marwick TH. Establishing the cost-effectiveness of percutaneous coronary intervention for chronic total occlusion in stable angina: a decision-analytic model. Heart. 2012 Dec;98(24):1790-7. doi: 10.1136/heartjnl-2012-302581. Epub 2012 Oct 4. PubMed 23038791 ↗
  • Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia's Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):284-90. doi: 10.1161/CIRCOUTCOMES.108.825760. Epub 2010 Apr 13. PubMed 20388873 ↗
  • Olivari Z, Rubartelli P, Piscione F, Ettori F, Fontanelli A, Salemme L, Giachero C, Di Mario C, Gabrielli G, Spedicato L, Bedogni F; TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol. 2003 May 21;41(10):1672-8. doi: 10.1016/s0735-1097(03)00312-7. PubMed 12767645 ↗
  • Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220. PubMed 29722796 ↗
  • Mashayekhi KA, Pyxaras SA, Werner GS, Galassi AR, Garbo R, Boudou N, Leibundgut G, Avran A, Bryniarski L, Bufe A, Sianos G, Di Mario C. Contemporary issues of percutaneous coronary intervention in heavily calcified chronic total occlusions: an expert review from the European CTO Club. EuroIntervention. 2023 Jun 5;19(2):e113-e122. doi: 10.4244/EIJ-D-22-01096. PubMed 36971414 ↗
  • Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024. PubMed 21349461 ↗
  • Christopoulos G, Kandzari DE, Yeh RW, Jaffer FA, Karmpaliotis D, Wyman MR, Alaswad K, Lombardi W, Grantham JA, Moses J, Christakopoulos G, Tarar MNJ, Rangan BV, Lembo N, Garcia S, Cipher D, Thompson CA, Banerjee S, Brilakis ES. Development and Validation of a Novel Scoring System for Predicting Technical Success of Chronic Total Occlusion Percutaneous Coronary Interventions: The PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) Score. JACC Cardiovasc Interv. 2016 Jan 11;9(1):1-9. doi: 10.1016/j.jcin.2015.09.022. PubMed 26762904 ↗
  • Maeremans J, Spratt JC, Knaapen P, Walsh S, Agostoni P, Wilson W, Avran A, Faurie B, Bressollette E, Kayaert P, Bagnall AJ, Smith D, McEntegart MB, Smith WHT, Kelly P, Irving J, Smith EJ, Strange JW, Dens J. Towards a contemporary, comprehensive scoring system for determining technical outcomes of hybrid percutaneous chronic total occlusion treatment: The RECHARGE score. Catheter Cardiovasc Interv. 2018 Feb 1;91(2):192-202. doi: 10.1002/ccd.27092. Epub 2017 May 4. PubMed 28471074 ↗
  • Szijgyarto Z, Rampat R, Werner GS, Ho C, Reifart N, Lefevre T, Louvard Y, Avran A, Kambis M, Buettner HJ, Di Mario C, Gershlick A, Escaned J, Sianos G, Galassi A, Garbo R, Goktekin O, Meyer-Gessner M, Lauer B, Elhadad S, Bufe A, Boudou N, Sievert H, Martin-Yuste V, Thuesen L, Erglis A, Christiansen E, Spratt J, Bryniarski L, Clayton T, Hildick-Smith D. Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry: The EuroCTO (CASTLE) Score. JACC Cardiovasc Interv. 2019 Feb 25;12(4):335-342. doi: 10.1016/j.jcin.2018.11.020. Epub 2019 Jan 30. PubMed 30711551 ↗
  • Opolski MP, Achenbach S, Schuhback A, Rolf A, Mollmann H, Nef H, Rixe J, Renker M, Witkowski A, Kepka C, Walther C, Schlundt C, Debski A, Jakubczyk M, Hamm CW. Coronary computed tomographic prediction rule for time-efficient guidewire crossing through chronic total occlusion: insights from the CT-RECTOR multicenter registry (Computed Tomography Registry of Chronic Total Occlusion Revascularization). JACC Cardiovasc Interv. 2015 Feb;8(2):257-267. doi: 10.1016/j.jcin.2014.07.031. PubMed 25700748 ↗
  • Panuccio G, Skurk C, Landmesser U, Abdelwahed YS. Double "full moon" CTO plaque detected by computed tomography could predict high-grade debulking techniques: A case-report. Clin Case Rep. 2023 May 18;11(5):e7325. doi: 10.1002/ccr3.7325. eCollection 2023 May. PubMed 37215968 ↗
  • Improvement N. 2019/20 National Tariff Payment System. In: system Ntp, editor. 2019.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Jul 2025, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2024
First posted
May 16, 2024
StartActual
Jul 19, 2024
Primary completionEst.
Jul 1, 2025
CompletionEst.
Jul 1, 2025
Last update
Aug 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06414551
Lead sponsor
Sandwell & West Birmingham Hospitals NHS Trust
Responsible party
Vinoda Sharma (Cardiology Specialty Lead, Honorary Associate Professor, Interventional Cardiologist, Sandwell & West Birmingham Hospitals NHS Trust) — Principal investigator
First posted
May 16, 2024
Start date
Jul 19, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Aug 30, 2024

Study contacts

Vinoda Sharma, FRCP
Contact
vinodasharma@nhs.net
+44(0)1215075841
Kelly Hard
Contact
swbh.randd.generic@nhs.net
+44(0)121 507 4811
Vinoda Sharma, FRCP
principal investigator · Sandwell & West Birmingham Hospitals NHS Trust

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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