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

NCT03745053 | Completed DMC

• 1 other identifier: XLIMIT
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 4

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Neointimal area

  6-month follow-up

• Number of Target lesion failure

  12-months follow-up

• Number of patients experiencig Cardiac death

  12-months follow-up

• Number of Target-vessel Myocardial infarction

  12-months follow-up

• Number of Target-lesion revascularization

  12-months follow-up

Study Arms (2)

XLIMUS DES

EXPERIMENTAL

Xlimus DES Implantation during coronary angioplasty

Device: Xlimus DES Implantation during coronary angioplasty

Synergy DES

ACTIVE COMPARATOR

Synergy DES Implantation during coronary angioplasty

Device: Synergy DES Implantation during coronary angioplasty

Interventions

Xlimus DES Implantation during coronary angioplasty DEVICE

Xlimus DES Implantation during coronary angioplasty

XLIMUS DES

Synergy DES Implantation during coronary angioplasty DEVICE

Synergy DES Implantation during coronary angioplasty

Synergy DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardionovum GmbH: lead
• Mediolanum Cardio Research: collaborator

Study Sites (4)

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, 20097, Italy

Location

Hospital Bellvitge

Barcelona, 08025, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Related Publications (2)

• 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.

  PMID: 37745092 BACKGROUND

• 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.

  PMID: 31061876 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Luca Testa, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The members of the Event Adjudication Committee and the Core Lab will be blinded to the patient assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized multi-centre controlled trial

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 19, 2018
• Study Start: February 5, 2019
• Primary Completion: September 2, 2023
• Study Completion: September 2, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (3)