The All-comers Sirolimus-coated Balloon European Registry

NCT03085823 | Completed

• 1 other identifier: fbf001
• Study Type: observational
• Target: 2,123
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Target lesion revascularization

  repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion

  12 months

Secondary Outcomes (4)

• Angiographic success

  10 minutes after percutaneous transluminal coronary angioplasty

• procedural success

  up to 48 hours

• major adverse cardiac events

  6, 12, 24 and 36 months

• very single component of major adverse cardiac events

  6, 12, 24 and 36 months

Interventions

Sirolimus Coated Balloon DEVICE

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

All patients with a clinical indication for PCI.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatebenefratelli and Ophthalmic Hospital: lead

Study Sites (1)

Unita' Operativa di Cardiologia

Milan, 20121, Italy

Location

Related Publications (1)

• 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.

  PMID: 37495352 DERIVED

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

• Bernardo Cortese

  Clinica San Carlo, Paderno Dugnano, MI, Italy

  PRINCIPAL INVESTIGATOR

• Antonio Colombo

  Humanitas Research Hospital, Rozzano, MI, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FESC

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: March 21, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2022
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

IT (1)