XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Xlimus DES Implantation during coronary angioplasty; Device: Synergy DES Implantation during coronary angioplasty

• Registration Number: NCT03745053
• Lead Sponsor: Cardionovum GmbH

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

Study Timeline

• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2019-02-05
• Primary Completion: 2023-09-02
• Study Completion: 2023-09-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XLIMUS DES	Xlimus DES Implantation during coronary angioplasty	Xlimus DES Implantation during coronary angioplasty
Synergy DES	Synergy DES Implantation during coronary angioplasty	Synergy DES Implantation during coronary angioplasty

Primary Outcome Measures

Name	Time	Method
In-stent neointimal volume	6-month follow-up	In-stent neointimal volume at 6-month follow-up, measured with OCT, as assessed by the Core-Lab. Neointimal volume will be calculated in all analyzed cross-sections and volumetric measurements and in stent neointimal volume will be compared in the two groups.

Secondary Outcome Measures

Name	Time	Method
Neointimal area	6-month follow-up	Neointimal area calculated at the site of minimal lumen area measured with OCT
Number of Target lesion failure	12-months follow-up	composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR)
Percentage of Lesion success at 24 hours	24 hours	attainment of \<50% residual stenosis of the target lesion using post-PCI
Number of Stent thrombosis	12-months follow-up	This is defined according to classification proposed by the Academic Research Consortium
Percentage of Procedural success at 24 hours	24 hours	lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay
Number of patients experiencig Cardiac death	12-months follow-up	Any death due to proximate cardiac cause (eg, MI, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death
Percentage of Device success at 24 hours	24 hours	deployment of the assigned stents without system failure or device-related complication
Number of Target-vessel Myocardial infarction	12-months follow-up	any MI that, irrespective of the time after the index procedure, is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. Type of acute MI is classified according to the Joint ESC/ACCF/AHA/ WHF Joint Task Force for the Universal Definition of Myocardial Infarction
Number of Target-lesion revascularization	12-months follow-up	repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI

Trial Locations

Locations (4)

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Bellvitge; 🇪🇸 Barcelona, Spain

IRCCS Policlinico S. Donato; 🇮🇹 San Donato Milanese, Milano, Italy

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain