Clinical trial NCT03745053: XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization
Official title: XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Cardionovum GmbH
Sponsor class: INDUSTRY
Collaborators: name: Mediolanum Cardio Research
First posted: 2018-11-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized multi-centre controlled trial
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty

Detailed description: The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment

Eligibility criteria: Inclusion Criteria:

1. Age≥18
2. Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI.
3. PCI considered appropriate and feasible
4. Culprit de novo lesion in a native coronary artery with significant stenosis (\>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length);
5. Patient provides written informed consent
6. Patient agrees to all required follow-up procedures and visits.
7. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
2. Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum;
3. Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer;
4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods;
5. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
6. Previous coronary intervention on target vessel in the 3-months prior to enrollment;
7. Non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
9. Previously documented left ventricular ejection fraction (LVEF) \<30%;
10. Evident cardiogenic shock before randomization;
11. Patients with left main stem stenosis (\>50% by visual estimate);
12. In-stent restenosis;
13. ST-segment elevation MI;
14. Chronic total occlusion/ heavily calcified lesions
15. Culprit lesion to a Saphenous Vein graft

Primary outcomes:
measure: In-stent neointimal volume
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Neointimal area
timeFrame: 6-month follow-up
measure: Number of Target lesion failure
timeFrame: 12-months follow-up
measure: Number of patients experiencig Cardiac death
timeFrame: 12-months follow-up
measure: Number of Target-vessel Myocardial infarction
timeFrame: 12-months follow-up
measure: Number of Target-lesion revascularization
timeFrame: 12-months follow-up
measure: Number of Stent thrombosis
timeFrame: 12-months follow-up
measure: Percentage of Device success at 24 hours
timeFrame: 24 hours
measure: Percentage of Lesion success at 24 hours
timeFrame: 24 hours
measure: Percentage of Procedural success at 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico S. Donato
state: Milano
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Luca Testa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Testa L, Squillace M, Ventrella N, Moreno R, Jimenez-Valero S, Serra A, Gomez Hospital JA, Bellamoli M, Popolo Rubbio A, Bedogni F. A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial. Front Cardiovasc Med. 2023 Sep 6;10:1199475. doi: 10.3389/fcvm.2023.1199475. eCollection 2023.
citation: Testa L, Pero G, Bollati M, Casenghi M, Popolo Rubbio A, Cuman M, Moreno R, Serra A, Gomez JA, Bedogni F. XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial. Int J Cardiol Heart Vasc. 2019 Apr 28;23:100363. doi: 10.1016/j.ijcha.2019.100363. eCollection 2019 Jun.