Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT06009757
Eligibility Criteria:
Inclusion Criteria:
* Patients need to be at least 18 years old.
* Patients with significant coronary artery disease who qualify for PCI (according to ACC/AHA/SCAI 2021 guidelines, including that the patient has received medical therapy with exercise and dietary recommendations before or at the same time as the PCI decision and that the clinical decision depends on the cardiology team) and who can be treated with a radial and femoral approach
* Patients scheduled for for Percutaneous Coronary Intervention and must remain overnight for observation
* The target vessel must have a TIMI flow 3 at baseline
* Palpable radial or fermoral artery
* Patients covered by the social security system
Exclusion Criteria:
* Concomitant use of Atherectomy, specialty balloon (intravascular lithotripsy), or investigational coronary devices (intravascular ultrasound, or optical coherence tomography)
* Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
* Prior PCI procedure within the last 30 days of the index procedure
* Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL.
* Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
* Target vessel \< 2.4 mm in diameter
* Target lesion \> 32 mm in length
* Patient has allergy to imaging contrast media for which they cannot be pre-medicated
* Patients with hypersensitivity or contraindication to antiplatelet treatment
* Patient unable to stop his or her daily oral medication includes metformin treatment during 48 hours.
* Unstable patient: myocardial infarction, cardiogenic shock or with troponin above the upper limit of the normal laboratory value in the 24 hours prior to the procedure OR with elevated troponin and abnormal concomitant CK (non-exhaustive list).
* Unable to follow the requirements of the protocol.
* Vulnerable: whose ability or freedom to give or refuse consent is limited.
* Patients who cannot read or write french;
* Major protected by law (tutorship, curatorship, safeguarding justice...).
* Patient is pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06009757
Study Brief:
Protocol Section:
NCT06009757