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Trial record 3 of 22 for:    bioflow biotronik

BIOFLOW-SV Portugal Registry (BIOFLOW-SV)

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ClinicalTrials.gov Identifier: NCT03600961
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Brief Summary:
Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm

Condition or disease Intervention/treatment
Ischemic Heart Disease Device: Orsiro Sirolimus Eluting Coronary Stent System

Detailed Description:
Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIOTRONIK - SaFety and Performance Registry for an Allcomers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels - Portugal Registry
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus


Intervention Details:
  • Device: Orsiro Sirolimus Eluting Coronary Stent System
    Percutaneous coronary intervention


Primary Outcome Measures :
  1. Target Lesion Failure for the small vessel group [ Time Frame: at 12 months ]
    Primary endpoint will be Target Lesion Failure (TLF) at 12 months for the small vessels group, defined as a composite of cardiac death, target vessel Myocardial Infarction (MI) or clinically driven Target Lesion Revascularization (TLR)


Secondary Outcome Measures :
  1. TLF for the overall cohort [ Time Frame: at 12 months ]
    TLF at 12 months post procedure for the overall cohort

  2. Clinically driven Target Lesion Revascularization (TLR) [ Time Frame: at 6 and 12 months ]
    Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure

  3. Clinically driven Target Vessel Revascularization (TVR) [ Time Frame: at 6 and 12 months ]
    Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure

  4. Definite and probable stent thrombosis [ Time Frame: at 6 and 12 months ]
    Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)

  5. Procedure success [ Time Frame: 12 months ]
    defined as achievement of a final diameter stenosis of <30% by investigator's visual estimate (using any percutaneous method) without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay

  6. Device success [ Time Frame: 12 months ]
    defined as a final residual diameter stenosis of <30% by investigator's visual estimate, using the assigned device only, successful delivery of the stent to the target lesion site in the coronary artery, appropriate stent deployment, and successful removal of the device. Post-dilatation is allowed to achieve device success



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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
This registry will include subjects requiring a treatment of coronary artery disease with an Orsiro DES
Criteria

Inclusion Criteria:

  • Subject is ≥18 years of age
  • Subject must sign a Patient Informed Consent (PIC) or a Patient Data Release Form (PDRF)
  • Subject must agree to undergo all required follow-up visits

Exclusion Criteria:

  • Pregnant and/or breast feeding females at the time of enrolment
  • Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant

    /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated

  • Currently participating in another study that has not yet reached the primary endpoint

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): NCT03600961


Contacts
Contact: Stephanie Sauter, Dr. +41 44 864 55 75 stephanie.sauter@biotronik.com

Locations
Portugal
Hospital de Santa Cruz Recruiting
Carnaxide, Portugal, 2799-134
Contact: Manuel Almeida, MD    +351936359285    Almeidams@sapo.pt   
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Pedro Braga, MD Centro Hospitalar de Vila Nova de Gaia

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT03600961     History of Changes
Other Study ID Numbers: C1704
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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