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The All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE)

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ClinicalTrials.gov Identifier: NCT03085823
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Bernardo Cortese, Fatebenefratelli and Ophthalmic Hospital

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.

Condition or disease Intervention/treatment
Percutaneous Coronary Intervention Angioplasty, Balloon, Coronary Coronary Angioplasty, Transluminal Balloon Arteriosclerosis, Coronary Device: Sirolimus Coated Balloon

Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: The All-comers Sirolimus-coated Balloon European Registry
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus




Primary Outcome Measures :
  1. Target lesion revascularization [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Angiographic success [ Time Frame: 10 minutes after percutaneous transluminal coronary angioplasty ]
    residual stenosis <50%, TIMI FLOW 3

  2. procedural success [ Time Frame: up to 48 hours ]
    angiographic success in absence of in-hospital events

  3. major adverse cardiac events (cardiac death, Acute myocardial infarction, target lesion revascularization) [ Time Frame: 6, 12 and 24 months ]
  4. very single component of major adverse cardiac events (cardiac death, Acute myocardial infarction, target lesion revascularization) [ Time Frame: 6, 12 and 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a clinical indication for PCI.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085823


Contacts
Contact: Bernardo Cortese, MD bcortese@gmail.com

Locations
Italy
Unita' Operativa di Cardiologia Recruiting
Milano, Italy, 20121
Contact: Bernardo Cortese, MD       bcortese@gmail.com   
Principal Investigator: Bernardo Cortese, MD         
Sponsors and Collaborators
Fatebenefratelli and Ophthalmic Hospital

Responsible Party: Bernardo Cortese, MD FESC, Fatebenefratelli and Ophthalmic Hospital
ClinicalTrials.gov Identifier: NCT03085823     History of Changes
Other Study ID Numbers: fbf001
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs