Coronary Artery DiseaseXLIMITNCT03745053

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

A study testing Xlimus DES Implantation during coronary angioplasty and Synergy DES Implantation during coronary angioplasty in people with Coronary Artery Disease, run by Cardionovum GmbH at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Xlimus DES Implantation during coronary angioplasty and Synergy DES Implantation during coronary angioplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 4 sitesin 2 countries
Study dates: 5 Feb 2019to 2 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 15Show fewer

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

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Spain3 sites

Hospital Bellvitge
Barcelona, 08025
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital La Paz
Madrid, 28046

Other trials in Spain

Italy1 site

IRCCS Policlinico S. Donato
San Donato Milanese, Milano, 20097

Other trials in Italy

About this study

Read the 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
Being tested: Xlimus DES Implantation during coronary angioplasty, Synergy DES Implantation during coronary angioplasty
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xlimus DES Implantation during coronary angioplastyDevice
Xlimus DES Implantation during coronary angioplasty
Synergy DES Implantation during coronary angioplastyDevice
Synergy DES Implantation during coronary angioplasty

Study groups in NCT03745053
Study group	Role	What they receive
XLIMUS DES	Experimental	Xlimus DES Implantation during coronary angioplasty Receives: Device: Xlimus DES Implantation during coronary angioplasty
Synergy DES	Active comparator	Synergy DES Implantation during coronary angioplasty Receives: Device: Synergy DES Implantation during coronary angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6-month follow-up

Secondary outcomes (9)

Neointimal area
Neointimal area calculated at the site of minimal lumen area measured with OCT
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 12-months follow-up
Number of Stent thrombosis
This is defined according to classification proposed by the Academic Research Consortium
Measured: 12-months follow-up
Percentage of Device success at 24 hours
deployment of the assigned stents without system failure or device-related complication
Measured: 24 hours
Percentage of Lesion success at 24 hours
attainment of <50% residual stenosis of the target lesion using post-PCI
Measured: 24 hours
Percentage of Procedural success at 24 hours
lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 20192 Sep 2023

First posted19 Nov 2018
Study start5 Feb 2019
Primary completion2 Sep 2023
Study completion2 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized multi-centre controlled trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03745053
Sponsor's protocol ID: XLIMIT
Acronym: XLIMIT
Status last verified: Feb 2024
First submitted: 9 Nov 2018
Last updated: 7 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37745092
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.
PubMed 31061876

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization
ClinicalTrials.gov ID: NCT03745053
Acronym / sponsor ID: XLIMIT / XLIMIT
Conditions: Coronary Artery Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Cardionovum GmbHIndustry (pharma, biotech, devices)
Collaborators: Mediolanum Cardio Research
Study start: 5 Feb 2019 (actual)
Primary completion: 2 Sep 2023 (actual)
Study completion: 2 Sep 2023 (actual)
First posted: 19 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Randomized multi-centre controlled trial

Arm	Type	Receives
XLIMUS DES	Experimental	Device: Xlimus DES Implantation during coronary angioplastyXlimus DES Implantation during coronary angioplasty
Synergy DES	Active comparator	Device: Synergy DES Implantation during coronary angioplastySynergy DES Implantation during coronary angioplasty

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xlimus DES Implantation during coronary angioplastyXlimus DES Implantation during coronary angioplasty	Device	XLIMUS DES
Synergy DES Implantation during coronary angioplastySynergy DES Implantation during coronary angioplasty	Device	Synergy DES

Primary outcome

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.

9 secondary outcomes

Neointimal area
Time frame: 6-month follow-up
Number of Target lesion failure
Time frame: 12-months follow-up
Number of patients experiencig Cardiac death
Time frame: 12-months follow-up
Number of Target-vessel Myocardial infarction
Time frame: 12-months follow-up
Number of Target-lesion revascularization
Time frame: 12-months follow-up
Number of Stent thrombosis
Time frame: 12-months follow-up
Percentage of Device success at 24 hours
Time frame: 24 hours
Percentage of Lesion success at 24 hours
Time frame: 24 hours
Percentage of Procedural success at 24 hours
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Background: PubMed 37745092Testa 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.
Results publication: PubMed 31061876Testa 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luca Testa, MD principal investigator

IRCCS Policlinico S. Donato

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent neointimal volume (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03745053, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.