Trial record 120 of 5865 for:    Arteriosclerosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03085823
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
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 ]

Information from the National Library of Medicine

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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.

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 identifier (NCT number): NCT03085823

Contact: Bernardo Cortese, MD

Unita' Operativa di Cardiologia Recruiting
Milano, Italy, 20121
Contact: Bernardo Cortese, MD   
Principal Investigator: Bernardo Cortese, MD         
Sponsors and Collaborators
Fatebenefratelli and Ophthalmic Hospital

Responsible Party: Bernardo Cortese, MD FESC, Fatebenefratelli and Ophthalmic Hospital 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:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs