The All-comers Sirolimus-coated Balloon European Registry

NCT ID: NCT03085823

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2022-01-31

Brief Summary

The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting Drug Coated Balloon for the treatment of any type of coronary lesions, including native vessel disease and in stent restenosis.

Detailed Description

The drug coated balloons (DCB) are one of the most promising innovations in the interventional cardiology field, and in some cases represent a valid alternative to stents. The numerous devices currently on the market, and the clinical results sometimes encouraging, sometimes less, have clearly shown that there is no "class" effect. The DCB so far available were conformed to elute only paclitaxel, an high lipophilicity drug with a narrow therapeutic window, cytotoxic at medium-high dosage.

The DCB allow the drug release without needing to implant prostheses in the coronary vessel; such prostheses (stents have been shown to be associated with an increased risk of thrombotic events, even years after implantation, caused by a non- healing of the vessel by the action of the drug itself or of the polymer, together with the presence of the metal of the stent . After a DCP angioplasty the absence of such implants, instead, ensures a quick recovery of the vessel function. Moreover, the absence of the prosthesis is particularly favorable in the case of small/medium diameter vessels, tortuous or severe calcific vessel, or for the treatment of in-stent restenosis.

In the Bello study, the DCB IN.PACT Falcon, has reached the non-inferiority expected (and also the superiority, not expected), against the same DES regarding the primary endpoint of late lumen loss (LLL) at the angiographic control. The results of this study, encouraging for the drug-eluting balloon technology, however, are tainted by a now obsolete technology, the use of an endpoint that supports the balloon (LLL), and the comparison with a DES that is no longer in trade and is objectively inferior to those used in 2016.

Several new generation DCB have been developed in the last years, with the aim of improving the paclitaxel release in the coronary wall, thus reducing the risk of restenosis. In addition, several improvements have involved the trackability and deliverability of these devices even in tortuous and small vessels . The latest generation DCB have several advantages compared to the old generation DCB: paclitaxel is layered with an inert support (matrix or carrier) using a multi-layer technology, improving both its release and the persistence in the vessel wall; furthermore, significant improvements have been made to address the poor deliverability of first generation balloons.

In 2016 the Magic Touch, a new type of DCB has obtained, first, the CE mark for marketing in Europe; it is characterized by eluting sirolimus, a drug with potent inhibitory effect on cell growth, but with low lipophilicity. For this reason, its ability to penetrate the wall of the vessel is limited, and so far it has not been possible to develop a device that would allow an effective release, despite the drug is now known for years in cardiology.

The purpose of this study is to evaluate the DCB Magic Touch performance in terms of efficacy and safety when used during coronary angioplasty, in a wide spectrum of coronary heart disease.

The primary objective of the study is to verify the rate of target vessel revascularization (TLR) at 12 months after implantation, both with new coronary angioplasty or coronary artery bypass graft.

Secondary objectives will be:

• angiographic success, defined as residual stenosis < 50% and TIMI 3 coronary flow; - procedural success, defined as angiographic success and absence of adverse cardiovascular events during initial hospitalization;
• major adverse cardiac events (MACE ), a composite endpoint of cardiac death, acute myocardial infarction and need for TLR at 6, 12, 24 and 36 months of implantation;
• every single element determining the MACE endpoint. This is a multicenter, prospective, spontaneous, observational, single-arm, clinical study, where will be enrolled patients with coronary artery disease and clinical indication for coronary angioplasty.

The indication for coronary angioplasty will be stable angina pectoris, silent ischemia or acute coronary syndrome (unstable angina or acute myocardial infarction).

Before participating all subjects will be informed about the study, including the possible risks and benefit, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or those angiographic, or that could satisfy at least one criterion for exclusion and therefore be excluded from the study (screening failure), even after informed consent.

Conditions

Percutaneous Coronary Intervention; Angioplasty, Balloon, Coronary; Coronary Angioplasty, Transluminal Balloon; Arteriosclerosis, Coronary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Sirolimus Coated Balloon

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age at least 18
• patients with symptomatic coronary artery disease (including chronic stable angina, silent ischemia, acute coronary syndromes) with clinical indication to percutaneous coronary intervention.

Exclusion Criteria

• patients with one or more of the following criteria: known (and untreatable) hypersensitivity or contraindication to Aspirin, Heparin, Clopidogrel, Prasugrel, Ticagrelor, Sirolimus, or a sensitivity to contrast media which cannot be adequately pre-medicated.
• patients enrolled in another trial.

Target lesion/vessel with any of the following characteristics:

• successful pre-dilatation not performed in the target lesion, or not efficacious (residual stenosis >50%);
• severe calcification of the target vessel, also proximal to the lesion;
• highly tortuous lesions which can impair access of device to treatment site.
• visible thrombus at lesion which is not treatable with aspiration.

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

Sponsors

Fatebenefratelli and Ophthalmic Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bernardo Cortese

MD FESC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernardo Cortese

Role: PRINCIPAL_INVESTIGATOR

Clinica San Carlo, Paderno Dugnano, MI, Italy

Antonio Colombo

Role: STUDY_CHAIR

Humanitas Research Hospital, Rozzano, MI, Italy

Locations

Unita' Operativa di Cardiologia

Milan, , Italy

Countries

Italy

References

Cortese B, Testa L, Heang TM, Ielasi A, Bossi I, Latini RA, Lee CY, Perez IS, Milazzo D, Caiazzo G, Tomai F, Benincasa S, Nuruddin AA, Stefanini G, Buccheri D, Seresini G, Singh R, Karavolias G, Cacucci M, Sciahbasi A, Ocaranza R, Menown IBA, Torres A, Sengottvelu G, Zanetti A, Pesenti N, Colombo A; EASTBOURNE Investigators. Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1794-1803. doi: 10.1016/j.jcin.2023.05.005.

Reference Type: DERIVED

PMID: 37495352 (View on PubMed)

Other Identifiers

fbf001

Identifier Type: -

Identifier Source: org_study_id