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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01918150
Eligibility Criteria:
Inclusion Criteria:
* Patient with symptomatic de novo coronary lesion involving one or two vessels
* Patient presenting a lesion with \> 50% stenosis
* Patient who must undergo a percutaneous coronary intervention (PCI) in the indications of Cobalt-chromium bare metal stents and TITAN2 stents and being able to be indifferently treated with one or the other of these stents.
* Written informed consent
* Expected survival \> 2 years
* Patient reachable by phone throughout the duration of the study.
Exclusion Criteria:
* Pregnant/Lactating women
* Women of childbearing potential (last menstrual period \<12 months) not using effective contraception
* Patient under legal protection
* Indication of coronary artery bypass graft surgery (CABG)
* History of coronary artery bypass graft surgery (CABG)
* Intrastent restenosis lesion
* Bifurcation lesion with the exception of those treated with a standardized approach (provisional stenting with final kissing in the side branch)
* Left main coronary lesion
* Ostial target lesion
* Previous drug-eluting stenting
* Previous bare metal stenting or balloon angioplasty in the 12 months prior the inclusion; if this implantation involved the target artery, separate the new implanted stent at a distance ≥ 10 mm.
* History of stent thrombosis
* Heavily calcified lesion
* Use of the Rotablator
* Left ventricular ejection fraction (LVEF) \< 30%
* Cardiac arrest, cardiogenic shock or severe heart failure (Killip stage III or IV)
* Severe chronic renal failure (creatinine clearance \<30 ml min)
* Cardiac or renal transplantation
* Major surgery within the last 14 days
* Surgery scheduled within 30 days (non-ACS patients) or 12 months (if ACS) at the time of the randomization
* History of major bleeding
* Pathology with major risk of bleeding or any condition, allergy or intolerance which is incompatible with anticoagulation and / or extended antiplatelet therapy
* Known allergy to Titanium, Nickel, Cobalt or Chromium
* Patient currently participating in another clinical trial
* Non-compliant patient (treatment and follow-up)
* Patient living abroad
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01918150
Study Brief:
Protocol Section:
NCT01918150