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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Xlimus DES Implantation during coronary angioplasty; Device: Synergy DES Implantation during 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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • IRCCS Policlinico S. Donato
• Spain
  • Barcelona, Spain, 08025
    • Hospital de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08025
    • Hospital Bellvitge
  • Madrid, Spain, 28046
    • Hospital La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XLIMUS DES; Xlimus DES Implantation during coronary angioplasty	Device: Xlimus DES Implantation during coronary angioplasty; Xlimus DES Implantation during coronary angioplasty
Active Comparator: Synergy DES; Synergy DES Implantation during coronary angioplasty	Device: Synergy DES Implantation during coronary angioplasty; Synergy DES Implantation during coronary angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent neointimal volume	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.	6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neointimal area	Neointimal area calculated at the site of minimal lumen area measured with OCT	6-month follow-up
Number of Target lesion failure	composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR)	12-months follow-up
Number of patients experiencig Cardiac death	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	12-months follow-up
Number of Target-vessel Myocardial infarction	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	12-months follow-up
Number of Target-lesion revascularization	repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI	12-months follow-up
Number of Stent thrombosis	This is defined according to classification proposed by the Academic Research Consortium	12-months follow-up
Percentage of Device success at 24 hours	deployment of the assigned stents without system failure or device-related complication	24 hours
Percentage of Lesion success at 24 hours	attainment of <50% residual stenosis of the target lesion using post-PCI	24 hours
Percentage of Procedural success at 24 hours	lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay	24 hours

Collaborators and Investigators

• Sponsor: Cardionovum GmbH
• Collaborators: Mediolanum Cardio Research
• Investigators: Principal Investigator: Luca Testa, MD, IRCCS Policlinico S. Donato

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): September 2, 2023
• Study Completion (Actual): September 2, 2023

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: XLIMIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No