BIOFLOW-SV All Comers Registry

Last updated: February 14, 2024
Sponsor: Biotronik AG
Overall Status: Terminated

Phase

N/A

Condition

Coronary Artery Disease

Myocardial Ischemia

Chest Pain

Treatment

Orsiro Sirolimus Eluting Coronary Stent System

Clinical Study ID

NCT03600948
C1607
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orby phone.
  • Subject with coronary artery disease requiring treatment with Orsiro Sirolimus elutingstent system

Exclusion

Exclusion Criteria:

  • Pregnant and/or breast feeding females at the time of enrolment
  • Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, heparin orany other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, orsimilar drugs, or the stent materials that cannot be adequately pre-medicated
  • Currently participating in another study that has not yet reached the primaryendpoint.

Study Design

Total Participants: 261
Treatment Group(s): 1
Primary Treatment: Orsiro Sirolimus Eluting Coronary Stent System
Phase:
Study Start date:
August 27, 2018
Estimated Completion Date:
October 06, 2021

Study 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.

Connect with a study center

  • Moinhos de Vento Hospital

    Porto Alegre, 90560-030
    Brazil

    Site Not Available

  • Hospital de Base

    São José do Rio Preto,
    Brazil

    Site Not Available

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