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

• Sponsor: Cardionovum GmbH
• Collaborator: Mediolanum Cardio Research
• Information provided by (Responsible Party): Cardionovum GmbH

Study Description

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

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: Xlimus DES Implantation during coronary angioplasty; Device: Synergy DES Implantation during coronary angioplasty	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Randomized multi-centre controlled trial
Masking:	Single (Outcomes Assessor)
Masking Description:	The members of the Event Adjudication Committee and the Core Lab will be blinded to the patient assignment.
Primary Purpose:	Treatment
Official Title:	XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization
Actual Study Start Date :	February 5, 2019
Estimated Primary Completion Date :	June 1, 2020
Estimated Study Completion Date :	January 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. In-stent neointimal volume [ Time Frame: 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 :

1. Neointimal area [ Time Frame: 6-month follow-up ]
   Neointimal area calculated at the site of minimal lumen area measured with OCT
2. Number of Target lesion failure [ Time Frame: 12-months follow-up ]
   composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR)
3. Number of patients experiencig Cardiac death [ Time Frame: 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
4. Number of Target-vessel Myocardial infarction [ Time Frame: 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
5. Number of Target-lesion revascularization [ Time Frame: 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
6. Number of Stent thrombosis [ Time Frame: 12-months follow-up ]
   This is defined according to classification proposed by the Academic Research Consortium
7. Percentage of Device success at 24 hours [ Time Frame: 24 hours ]
   deployment of the assigned stents without system failure or device-related complication
8. Percentage of Lesion success at 24 hours [ Time Frame: 24 hours ]
   attainment of <50% residual stenosis of the target lesion using post-PCI
9. Percentage of Procedural success at 24 hours [ Time Frame: 24 hours ]
   lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Contacts

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Contact: Nadia Moffa, BSc	0039 026125141	moffa@mcr-med.com
Contact: Maria Cristina Jori, MD	0039 026125141	jori@mcr-med.com

Locations

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Italy
IRCCS Policlinico S. Donato	Recruiting
San Donato Milanese, Milano, Italy, 20097
Contact: Luca Testa, MD 00390252774987 luctes@gmail.com
Principal Investigator: Luca Testa, MD
Spain
Hospital Bellvitge	Not yet recruiting
Barcelona, Spain, 08025
Contact: Joan Antoni Gómez Hospital, MD
Principal Investigator: Joan Antoni Gómez Hospital, MD
Hospital de la Santa Creu i Sant Pau	Not yet recruiting
Barcelona, Spain, 08025
Contact: Antoni Serra, MD
Principal Investigator: Antoni Serra, MD
Hospital La Paz	Not yet recruiting
Madrid, Spain, 28046
Contact: José Raúl Moreno Gómez, MD raulmorenog@hotmail.com
Principal Investigator: José Raúl Moreno Gómez, MD

Sponsors and Collaborators

Cardionovum GmbH

Mediolanum Cardio Research

Investigators

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Principal Investigator:	Luca Testa, MD	IRCCS Policlinico S. Donato

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Testa L, Pero G, Bollati M, Matteo C, 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.

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Responsible Party:	Cardionovum GmbH
ClinicalTrials.gov Identifier:	NCT03745053 History of Changes
Other Study ID Numbers:	XLIMIT
First Posted:	November 19, 2018
Last Update Posted:	March 20, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases