XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization (XLIMIT)
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ClinicalTrials.gov Identifier: NCT03745053 |
Recruitment Status :
Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : March 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Device: Xlimus DES Implantation during coronary angioplasty Device: Synergy DES Implantation during coronary angioplasty | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | March 2, 2021 |
Estimated Study Completion Date : | April 2, 2022 |
Arm | Intervention/treatment |
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Experimental: XLIMUS DES
Xlimus DES Implantation during coronary angioplasty
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Device: Xlimus DES Implantation during coronary angioplasty
Xlimus DES Implantation during coronary angioplasty |
Active Comparator: Synergy DES
Synergy DES Implantation during coronary angioplasty
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Device: Synergy DES Implantation during coronary angioplasty
Synergy DES Implantation during coronary angioplasty |
- 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.
- Neointimal area [ Time Frame: 6-month follow-up ]Neointimal area calculated at the site of minimal lumen area measured with OCT
- 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)
- 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
- 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
- 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
- Number of Stent thrombosis [ Time Frame: 12-months follow-up ]This is defined according to classification proposed by the Academic Research Consortium
- Percentage of Device success at 24 hours [ Time Frame: 24 hours ]deployment of the assigned stents without system failure or device-related complication
- Percentage of Lesion success at 24 hours [ Time Frame: 24 hours ]attainment of <50% residual stenosis of the target lesion using post-PCI
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age≥18
- Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI.
- PCI considered appropriate and feasible
- 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);
- Patient provides written informed consent
- Patient agrees to all required follow-up procedures and visits.
- Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm
Exclusion Criteria:
- 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);
- Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum;
- Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer;
- 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;
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
- Previous coronary intervention on target vessel in the 3-months prior to enrollment;
- Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- Previously documented left ventricular ejection fraction (LVEF) <30%;
- Evident cardiogenic shock before randomization;
- Patients with left main stem stenosis (>50% by visual estimate);
- In-stent restenosis;
- ST-segment elevation MI;
- Chronic total occlusion/ heavily calcified lesions
- Culprit lesion to a Saphenous Vein graft

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745053
Italy | |
IRCCS Policlinico S. Donato | |
San Donato Milanese, Milano, Italy, 20097 | |
Spain | |
Hospital Bellvitge | |
Barcelona, Spain, 08025 | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital La Paz | |
Madrid, Spain, 28046 |
Principal Investigator: | Luca Testa, MD | IRCCS Policlinico S. Donato |
Responsible Party: | Cardionovum GmbH |
ClinicalTrials.gov Identifier: | NCT03745053 |
Other Study ID Numbers: |
XLIMIT |
First Posted: | November 19, 2018 Key Record Dates |
Last Update Posted: | March 15, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |