ABLUMINUS NP Polymer Free Sirolimus-Eluting Stent Registry at Geneva University Hospitals (ABLUMINUS-GVA)

NCT07563231 | Not Yet Recruiting

• 2 other identifiers: ABLUMINUS-GVA-2026ABLUMINUS-GVA v1 04.03.2026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

ABLUMINUS-GVA is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the ABLUMINUS NP polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI) at Geneva University Hospitals. The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Approximately 50 patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Stent Thrombosis; Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

drug-eluting stent; polymer-free stent; sirolimus; ABLUMINUS NP; percutaneous coronary intervention; target lesion failure; registry; real-world evidence

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  Device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation, defined per Academic Research Consortium-2 (ARC-2) criteria. Binary categorical variable analysed by time-to-first-event method.

  12 months

Secondary Outcomes (10)

• Target Lesion Failure (TLF) at 2 and 5 years

  2 years; 5 years

• Cardiac death

  30 days; 12 months; 2 years; 5 years

• Target vessel myocardial infarction

  30 days; 12 months; 2 years; 5 years

• Clinically indicated target lesion revascularisation

  30 days; 12 months; 2 years; 5 years

• Patient-oriented composite endpoint (POCE)

  12 months; 2 years; 5 years

Study Arms (1)

ABLUMINUS NP cohort

Consecutive adult patients who received at least one ABLUMINUS NP polymer-free sirolimus-eluting stent during PCI at Geneva University Hospitals between January 2021 and December 2025. No study-mandated procedures; clinical care follows standard institutional practice.

Device: ABLUMINUS NP polymer-free sirolimus-eluting stent

Interventions

ABLUMINUS NP polymer-free sirolimus-eluting stent DEVICE

Thin-strut (73 micrometres) cobalt-chromium coronary stent with polymer-free submicron phospholipid carriers (200-300 nm) delivering sirolimus exclusively to the abluminal surface, and fusion coating extending sirolimus deposition up to 5 mm beyond the stent edges. CE-marked 24 January 2020. Available diameters 2.25-4.0 mm and lengths 8-40 mm. Manufactured by Concept Medical, Tampa, FL, USA. Implantation and peri-procedural care follow operator discretion and institutional standard of care.

ABLUMINUS NP cohort

Eligibility Criteria

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

Study Population

Consecutive adult patients who underwent percutaneous coronary intervention with implantation of at least one ABLUMINUS NP sirolimus-eluting stent at Geneva University Hospitals between January 2021 and December 2025.

You may qualify if:

• Age \>= 18 years at the time of the index procedure.
• Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.
• Implantation of at least one ABLUMINUS NP sirolimus-eluting stent.
• Indication for PCI according to current European or American guidelines.
• Able and willing to provide written informed consent.
• Sufficient knowledge of French, German, English, or Italian to understand the patient information document.

You may not qualify if:

• Documented refusal to participate in research through opt-out from general consent.
• Inability to provide informed consent (cognitive impairment or other).
• Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).
• Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.
• Participation in another clinical trial that would interfere with the endpoints of this registry.

Sponsors & Collaborators

• Dorian Garin: lead

Study Sites (1)

Geneva University Hospitals (HUG) - Service of Cardiology

Geneva, 1211, Switzerland

Location

Related Publications (3)

• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

  PMID: 29891620 BACKGROUND

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.

  PMID: 30165617 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Juan F Iglesias, MD, FESC, FACC

  Geneva University Hospitals (HUG), Interventional Cardiology Unit

  PRINCIPAL INVESTIGATOR

• Dorian Garin, MD

  Geneva University Hospitals (HUG), Department of Cardiology

  STUDY DIRECTOR

Central Study Contacts

Juan F Iglesias, MD, FESC, FACC

CONTACT

+41 22 372 72 00; juanFernando.Iglesias@hug.ch

Dorian Garin, MD

CONTACT

dorian.garin@hug.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Dorian Garin, MD

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2032
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting 6 months after publication of the primary 12-month results, without predefined end date.
• Access Criteria: Reasonable written request to the sponsor-investigator; institutionally approved research protocol; signed data sharing agreement; approval of the competent cantonal ethics committee.

Locations

CH (1)