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Computed Tomography Scan in Complex Chronic Total Occlusion Percutaneous Coronary Intervention;

ConditionTotal Occlusion of Coronary Artery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorElsan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥ 18 years old and ≤ 90 years old,

BMI ≤ 40 kg/m²,

Dated and signed informed consent, before any study-related procedures

Ability to understand and comply with the study procedures,

Disqualifiers

Pregnant or breastfeeding woman,

Adults patients protected by law,

Very frequent and irregular cardiac rhythm (>100/min.),

More than one CTO to be treated by PCI,

Trial design

Design model

Parallel

Treatments tested in this trial

  • CT scan

    Procedure/Surgery

    Surgeon will perform a CT scan before the surgery procedure (CTO PCI) in order to increase the success rate of the surgery.

  • No CT scan

    Procedure/Surgery

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: CT scanExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with successful CTO PCI procedure in both groups

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.

Time frame
Immediately after surgery.

Secondary outcomes

1

Total time of CTO PCI procedure

Duration of the surgery procedure given in minutes.

Time frame
Immediately after surgery.
2

Rate of CTO PCI complications

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.

Time frame
6 months starting from the date of the surgery.
3

Radiation level used during the CTO PCI procedure

Quantity of radiation used during the PCI (airKerma in Gy, DAP mGycm², fluoroscopy time in minutes).

Time frame
Immediately after surgery.
4

Volume of iodine contrast medium used for the CTO PCI procedure

Quantity of iodine contrast medium used during the PCI (given in milliliters).

Time frame
Immediately after surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elsan

Lead sponsor

Source ClinicalTrials.gov
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