Coronary stenosis Stent thrombosis
Conditions
Interventions
The *Cre8** stent is a polymer-free stent with a thin (80-µm) cobalt-chromium
alloy L605, integrally coated by an ultra-thin (0.3-µm) passive carbon coating
(i-Carbofilm, CID, Saluggia, Italy). The
Sponsors
R&D Cardiologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria a. All-comer patients 18 years and older; b. Patient has been informed of the nature of the trial and agrees to its provisions and has provided either oral during emergency procedure, followed by written informed consent, or written informed consent in case of an elective procedure as approved by the Medical Research Ethics Committee (MREC) c. Patient is eligible for percutaneous coronary intervention (PCI) with implantation of a drug-eluting stent d. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, NSTEMI or STEMI, silent ischemia, or a positive functional studyAngiographic Criteria a. All de-novo and restenotic lesions (whether native coronary or bypass graft) not amenable for treatment with drug eluting balloons b. All lesions types are allowed: calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy is allowed), thrombus, chronic total occlusion (CTO; randomized after successful wire crossing and pre-dilatation), bifurcation lesions, ostial lesions and left main. c. There is no limit for lesion length, or number of lesions or diseased vessels. d. Target vessel reference size (visual estimation) between 2.5 and 4.5 mmumwaar
Exclusion criteria
Exclusion criteria: Exclusion Criteria a. Inability to provide informed consent b. Participation in another study for intracoronary stents that had not reached its primary endpoint c. Planned surgery within the next 3 months d. 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 drug-eluting stents e. Female of childbearing potential, who are pregnant or are planning to become pregnant f. Life expectancy of less than 12 months g.Patients undergoing revascularization prior to planned TAVI procedure Angiographic Criteria: a. Lesions amenable for treatment with drug eluting balloons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be evaluated at 12 months of follow up post-procedure: * Target-Lesion Failure (TLF), consisting of: cardiac death, Target-Vessel Myocardial Infarction (QWMI and NQWMI), or Target-Lesion revascularization Revascularization by CABG or PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Net Adverse Clinical Events (NACE) defined as composite of: any death, myocardial infarction, stroke, any unplanned repeated revascularization and bleeding (BARC 3a and above), and separate components of the endpoints at 12- months post-procedure: * Target-Vessel revascularization by CABG or PCI (TVR) * Stent thrombosis * Device-, lesion-, and procedure success at time of baseline procedure | — |
Countries
Netherlands
Outcome results
None listed