Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BIOFLOW-SV All Comers Registry (BIOFLOW-SV)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03600948
Recruitment Status : Unknown
Verified September 2018 by Biotronik AG.
Recruitment status was:  Recruiting
First Posted : July 26, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
de Novo Symptomatic Ischemic Heart Disease Restenoses, Coronary 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Target Lesion Failure for the small vessel group [ Time Frame: 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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:

  • Subjects ≥18 years of Age
  • Subject must sign a Patient Informed Consent (PIC)
  • Subject must agree to undergo all required follow-up visits, either at the hospital or by phone.
  • Subject with coronary artery disease requiring treatment with Orsiro Sirolimus eluting stent system

Exclusion Criteria:

  • Pregnant and/or breast feeding females at the time of enrolment
  • Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03600948


Contacts
Layout table for location contacts
Contact: Stephanie Sauter, Dr +41 44 864 55 75 stephanie.sauter@biotronik.com
Contact: Stephanie Barbosa +55(11) 3372-8900 stephanie.barbosa@biotronik.com

Locations
Layout table for location information
Brazil
Moinhos de Vento Hospital Recruiting
Porto Alegre, Brazil, 90560-030
Contact: Marco Weinstain, MD    +55 51 33143434    mvwainstein@uol.com.br   
Hospital de Base Recruiting
São José do Rio Preto, Brazil
Contact: Marcios Santos, MD         
Sponsors and Collaborators
Biotronik AG
Investigators
Layout table for investigator information
Principal Investigator: Marco Weinstain, MD Moinhos de Vento Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT03600948    
Other Study ID Numbers: C1607
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Coronary Stenosis
 Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs