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

NCT ID: NCT03745053

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2023-09-02

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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

XLIMUS DES

Xlimus DES Implantation during coronary angioplasty

Group Type: EXPERIMENTAL

Xlimus DES Implantation during coronary angioplasty

Intervention Type: DEVICE

Xlimus DES Implantation during coronary angioplasty

Synergy DES

Synergy DES Implantation during coronary angioplasty

Group Type: ACTIVE_COMPARATOR

Synergy DES Implantation during coronary angioplasty

Intervention Type: DEVICE

Synergy DES Implantation during coronary angioplasty

Interventions

Xlimus DES Implantation during coronary angioplasty

Xlimus DES Implantation during coronary angioplasty

Intervention Type: DEVICE

Synergy DES Implantation during coronary angioplasty

Synergy DES Implantation during coronary angioplasty

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mediolanum Cardio Research

OTHER

Sponsor Role: collaborator

Cardionovum GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Testa, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico S. Donato

Locations

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, Italy

Hospital Bellvitge

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital La Paz

Madrid, , Spain

Countries

Italy; Spain

References

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.

Reference Type: BACKGROUND

PMID: 37745092 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31061876 (View on PubMed)

Other Identifiers

XLIMIT

Identifier Type: -

Identifier Source: org_study_id