Phase
Condition
Acute Pain
Cardiovascular Disease
Vascular Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: General Inclusion Criteria:
All-comer patients aged 18 years and older
Patient has been informed of the nature of the trial and agrees to its provisions andhas provided either oral during emergency procedure, followed by written informedconsent, or written informed consent in case of an elective procedure as approved bythe Medical Research Ethics Committee (MREC) of the respective investigational site
Patient is eligible, according to heart team decision if applicable, for PCI withimplantation of a drug-eluting stent (DES)
Patient has clinical evidence of ischemic heart disease, angina pectoris, myocardialinfarction, or silent ischemia Angiographic Inclusion Criteria:
All de-novo lesions and all restenotic lesions (whether native coronary or bypassgraft), not amenable for treatment with drug eluting balloons
All lesions types are allowed: calcified lesions (lesion preparation withscoring/cutting and rotational atherectomy are allowed), thrombus, chronic totalocclusion (CTO; randomized after successful wire crossing and pre-dilatation),bifurcation lesions, ostial lesions, bypass graft (venous and arterial) lesions andleft main.
There is no limit for lesion length; overlapping stents are allowed, or number oflesions or diseased vessels.
Target vessel size reference (visual estimation) between 2.5 mm and 4.5 mm.
Exclusion
Exclusion Criteria:
Inability to provide informed consent
Participation in another study for intracoronary stents that had not reached itsprimary endpoint
Planned surgery within the next 3 months
Known intolerance to P2Y12 receptor antagonist that would prevent adherence to DAPT,or intolerance to aspirin, clopidogrel, Ticagrelor, Prasugrel, heparin/bivalirudin,contrast agent (that cannot be adequately premedicated) or component of DES
Female of childbearing potential, who are pregnant or are planning to become pregnant
Life expectancy of less than 12 months
Study Design
Study Description
Connect with a study center
Institute of Cardiac Surgery and Interventional Cardiology
Luxembourg,
LuxembourgActive - Recruiting
Zuyderland Medical Centre
Heerlen,
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht, 3584CM
NetherlandsActive - Recruiting
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