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

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ClinicalTrials.gov Identifier: NCT04549896
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Elsan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Total Occlusion of Coronary Artery Procedure: CT scan Procedure: No CT scan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total time of CTO PCI procedure [ Time Frame: Immediately after surgery. ]
    Duration of the surgery procedure given in minutes.

  2. 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.

  3. 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).

  4. 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).

  5. Cost of the the CTO PCI procedure [ Time Frame: Immediately after surgery. ]
    Total cost of the surgery procedure (given in euros).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Troponin measure [ Time Frame: Baseline. ]
    Levels of troponin will be reported.

  12. CK measure [ Time Frame: Baseline. ]
    Levels of CK will be reported.

  13. Creatinine measure [ Time Frame: Baseline. ]
    Levels of creatinine will be reported.

  14. clearance of creatinine measure [ Time Frame: Baseline. ]
    Levels of the clearance of creatinine will be reported.

  15. Hemoglobin measure [ Time Frame: Baseline. ]
    Levels of hemoglobin will be reported.

  16. Troponin measure [ Time Frame: 24 hours after surgery ]
    Levels of troponin will be reported after the PCI at the CTO PCI visit.

  17. CK measure [ Time Frame: 24 hours after surgery ]
    Levels of CK will be reported after the PCI at the CTO PCI visit.

  18. Creatinine measure [ Time Frame: 24 hours after surgery ]
    Levels of creatinine will be reported after the PCI at the CTO PCI visit.

  19. 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.

  20. Hemoglobin measure [ Time Frame: 24 hours after surgery ]
    Levels of hemoglobin will be reported after the PCI at the CTO PCI visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549896


Contacts
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Contact: Eugenio LA SCALA, MD (0)4 94 06 98 82 ext +33 epflascala@hotmail.com

Locations
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France
Polyclinique Les Fleurs
Ollioules, France, 83190
Contact: Eugenio La Scala, MD    (0)4 94 06 98 82 ext +33    epflascala@hotmail.com   
Sub-Investigator: Paul BARRAGAN, MD         
Sub-Investigator: Philippe COMMEAU, MD         
Sub-Investigator: Pierre ROQUEBERT, MD         
Sponsors and Collaborators
Elsan
More Information
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Publications:

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Responsible Party: Elsan
ClinicalTrials.gov Identifier: NCT04549896    
Other Study ID Numbers: CTS-C-CTOPCI
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No