Computed Tomography Scan in Complex Chronic Total Occlusion Percutaneous Coronary Intervention; (CTS-C-CTOPCI)

August 23, 2023 updated by: Elsan

Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).

The chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. With this study, the investigators want to adress the impact of CT scan performed before the surgical procedure. A better knowledge of the patient's anatomy could lead to a better success rate of the operation, with a lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A chronic total occlusion (CTO) is the complete obstruction of a coronary artery that has been established from more than 3 months with TIMI (Thrombolysis in Myocardial Infarction) 0 flow. This is a frequent pathology, demonstrated in 20% of patients studied with a coronary angiography. The patients affected by an isolated CTO or by a multi-vascular coronary disease with one or more CTO are an heterogenous population in relation to age, co-morbidity, risk factors.

The treatment of this disease is medical, interventional or surgical. The interventional option is often the first choice in case of symptoms or ischemia associated with viability of the myocardial wall, originally perfused by the occluded segment. Medical treatment is often not enough to reduce symptoms and to improve quality of life. Surgery is very invasive, especially for patients with mono-vascular disease, not always possible, especially in case of distal diffuse disease or heavy co-morbidity.

The Percutaneous Coronary Intervention (PCI) is a good option thanks to the improvement of materials and recanalization techniques (anterograde, retrograde and dissection re-entry). However, the procedure is often long, expensive, using a lot of contrast medium and X ray.

At the diagnosis stage of a CTO, the Japan Chronic Total Occlusion (J-CTO) score defines the complexity of the procedure : 0 easy, 1 intermediate, 2 hard, ≥ 3 very hard. The score is actually calculated with the angiography data after evaluation of the occlusion's proximal cap shape, presence of calcifications in the occluded segment, tortuosity of the occluded segment and length of the occlusion.

In addition to the angiography data, a CT scan of coronary artery can be performed as part of Standard of Care. In the study's coordinating center, more than 2000 CT scans are performed by the team of interventional cardiologists. Data generated from last generation CT scan are then interpreted to extrapolate informations about the occluded segment, the occluded artery and the contralateral artery.

CT scan is able to identify very well the calcium distribution in the occluded segment/artery, the true length of the occlusion, bends, collateral branches, distal vessel anatomy, coronary path and more, solving ambiguity of proximal cap and showing the shape of the distal cap. Thanks to this investigation, the investigators can better evaluate the J-CTO score and the CT Rector score. The CT Rector score is helping to grade the CTO difficulty before the PCI by predicting time-efficient guidewire crossing. The investigators can calculate the calcium score of the occluded artery to detect a critical value for the success of CTO PCI. The best strategy with appropriate material can then be chosen for the procedure PCI.

In this study, the investigators would like to demonstrate the interest in performing a CT scan as a part of the pathology diagnosis before the PCI in more complex occlusions (J-CTO score ≥ 2). The investigators think that the CT scan, with a last generation GE Revolution 256 slice machine, is actually the best method to evaluate the J-CTO score, the CT Rector score and to obtain other important information like anatomical position of the occluded artery and presence of side branches in the occluded segment.

A better evaluation of J-CTO score and complex anatomy will then allow the selection of the best technique for the procedure with probably a better success rate, lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Ollioules, France, 83190
        • Recruiting
        • Polyclinique les Fleurs
        • Contact:
        • Sub-Investigator:
          • Paul BARRAGAN, MD
        • Sub-Investigator:
          • Philippe COMMEAU, MD
        • Sub-Investigator:
          • Pierre ROQUEBERT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years old and ≤ 90 years old,
  2. BMI ≤ 40 kg/m²,
  3. Dated and signed informed consent, before any study-related procedures
  4. Ability to understand and comply with the study procedures,
  5. Affiliate or recipient of a social security scheme,
  6. Coronary artery chronic total occlusion (TIMI 0 flow from > 3 months) associated with myocardial viability (intended like normokinetic/hypokinetic wall motion or instrumental data in favor of viability) associated with ≥ CCS2 angina or ≥ NHYA2 dyspnea or documented ischemia or ejection fraction <50%.
  7. Coronary angiography J-CTO score ≥ 2 (complex cases)

Exclusion Criteria:

  1. Pregnant or breastfeeding woman,
  2. Adults patients protected by law,
  3. Very frequent and irregular cardiac rhythm (>100/min.),
  4. More than one CTO to be treated by PCI,
  5. Coronary angiography J-CTO (Japan Chronic Total Occlusion) score 0/1
  6. Hemodynamic instability,
  7. Anemia < 9g/dl,
  8. Gastrointestinal bleeding,
  9. Thrombocytopenia with < 50 000/mm3 platelets count,
  10. Severe valvular disease associated
  11. CT-Scan performed as part of the standard of care pathology diagnosis, before the inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT scan
CT scan with a last generation 256 slice machine of occluded coronary artery before CTO PCI
Procedure: CT scan
Surgeon will perform a CT scan before the surgery procedure (CTO PCI) in order to increase the success rate of the surgery.
Active Comparator: Control
No CT scan before CTO PCI
Procedure: No CT scan
The surgery procedure (CTO PCI) will be performed following the standard of care, meaning that the surgeon will not perform a CT scan before the surgery procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with successful CTO PCI procedure in both groups
Time Frame: Immediately after surgery.
TIMI 3 flow restoration and residual stenosis < 30%, by wire crossing in less than (≤) 60 minutes guidewire manipulation. TIMI flow and residual stenosis will be evaluated by a pool of 2 cardiologists not involved in the procedure and blinded regarding the randomized group.
Immediately after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time of CTO PCI procedure
Time Frame: Immediately after surgery.
Duration of the surgery procedure given in minutes.
Immediately after surgery.
Rate of CTO PCI complications
Time Frame: 6 months starting from the date of the surgery.
Death, coronary perforation with cardiac tamponade requiring pericardiocentesis, myocardial infarction (if elevation of troponin/CK associated with change in electrocardiogram), stroke, major bleeding with lost of hemoglobin > 3g/dl.
6 months starting from the date of the surgery.
Radiation level used during the CTO PCI procedure
Time Frame: Immediately after surgery.
Quantity of radiation used during the PCI (airKerma in Gy, DAP mGycm², fluoroscopy time in minutes).
Immediately after surgery.
Volume of iodine contrast medium used for the CTO PCI procedure
Time Frame: Immediately after surgery.
Quantity of iodine contrast medium used during the PCI (given in milliliters).
Immediately after surgery.
Cost of the the CTO PCI procedure
Time Frame: Immediately after surgery.
Total cost of the surgery procedure (given in euros).
Immediately after surgery.
Creatinine level before discharge
Time Frame: 24 hours after surgery
This endpoint summarizes the renal adverse events in both groups. A baseline creatinine level is always known before the coronary angiography that initializes the diagnostic and therapeutic pathway.
24 hours after surgery
Safety assessed with Adverse Events reporting
Time Frame: 6 months starting from the date of the surgery.
Any adverse events will be reported (like contrast allergic reaction). Their relationship with the CT scan or PCI procedure will also be reported.
6 months starting from the date of the surgery.
Angina and dyspnea
Time Frame: 6 months starting from the date of the inclusion.
Symptoms (angina CCS class / dyspnea NYHA (New York Heart Association) class) will be collected at the CTO PCI visit and EOS visit.
6 months starting from the date of the inclusion.
Major Adverse Cardiac Events
Time Frame: 6 months starting the date of the inclusion.
Major Adverse Cardiac Events (MACE: myocardial infarction, cardiovascular death, revascularization, stroke) will be collected at the CTO PCI visit and EOS visit.
6 months starting the date of the inclusion.
renal failure collection
Time Frame: 6 months starting the date of the inclusion.
Renal failure will be collected at the CTO PCI visit and EOS visit.
6 months starting the date of the inclusion.
Troponin measure
Time Frame: Baseline.
Levels of troponin will be reported.
Baseline.
CK measure
Time Frame: Baseline.
Levels of CK will be reported.
Baseline.
Creatinine measure
Time Frame: Baseline.
Levels of creatinine will be reported.
Baseline.
clearance of creatinine measure
Time Frame: Baseline.
Levels of the clearance of creatinine will be reported.
Baseline.
Hemoglobin measure
Time Frame: Baseline.
Levels of hemoglobin will be reported.
Baseline.
Troponin measure
Time Frame: 24 hours after surgery
Levels of troponin will be reported after the PCI at the CTO PCI visit.
24 hours after surgery
CK measure
Time Frame: 24 hours after surgery
Levels of CK will be reported after the PCI at the CTO PCI visit.
24 hours after surgery
Creatinine measure
Time Frame: 24 hours after surgery
Levels of creatinine will be reported after the PCI at the CTO PCI visit.
24 hours after surgery
clearance of creatinine measure
Time Frame: 24 hours after surgery
Levels of the clearance of creatinine will be reported after the PCI at the CTO PCI visit.
24 hours after surgery
Hemoglobin measure
Time Frame: 24 hours after surgery
Levels of hemoglobin will be reported after the PCI at the CTO PCI visit.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CTS-C-CTOPCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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