BIOTRONIK - A Prospective Multicenter Study to Confirm the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - VII

Biotronik, Inc.33 sites in 1 country556 target enrollmentJanuary 24, 2020

ConditionsCoronary Artery Disease Atherosclerosis, Coronary Myocardial Ischemia Ischemic Heart Disease Acute Coronary Syndrome Angina Pectoris

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Biotronik, Inc.
Enrollment: 556
Locations: 33
Primary Endpoint: Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

Detailed Description

BIOFLOW-VII is a prospective, multicenter, single-arm study. Subjects with coronary artery disease (CAD) who undergo an on-label percutaneous coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened post-index procedure per the protocol inclusion and exclusion criteria. Following the index procedure and study enrollment, subjects will be followed for 5 years. The follow-up schedule will include an intermediate study visit at 1 month, a primary endpoint study visit at 12 months, and long-term study visits at 2, 3, 4, and 5 years.

Registry

clinicaltrials.gov

Start Date

January 24, 2020

End Date

January 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Biotronik, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥18 years of age.
•Subject was an acceptable candidate for treatment with a drug eluting stent at the qualifying index procedure, in accordance with the applicable guidelines on percutaneous coronary interventions and manufacturer's Instructions for Use.
•Subject received at least one Orsiro stent during an index procedure occurring within 24 hours prior to informed consent, as assessed by the end time of procedure. If more than one stent was implanted during the index procedure, all stents were Orsiro stents.
•Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.
•Subject is willing to comply with study follow-up requirements.
•Subject has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. Legally authorized representatives are not allowed to consent on a subject's behalf.
•Each target lesion/vessel must have met all of the following angiographic criteria from the index procedure for the subject to be eligible for the trial:
•Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel).
•Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
•Target lesion must be in major coronary artery or branch (target vessel).

Exclusion Criteria

•Subject had clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure.
•Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
•Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), silicon carbide, PLLA, sirolimus.
•Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure or any PCI planned within the next 1 year.
•Presence of an untreated clinically significant stenosis post-procedure whether treatment is planned or not.
•Planned surgery within 6 months of index procedure unless DAPT can be maintained throughout the peri-surgical period.
•History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
•Subject has documented LVEF \< 30% prior to consent.
•Subject is dialysis-dependent.
•Subject has impaired renal function (blood creatinine \> 2.5 mg/dL or 221 μmol/L prior to the index procedure).

Outcomes

Primary Outcomes

Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure

Time Frame: 12-Months

TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).

Secondary Outcomes

Protocol-defined Any-vessel Myocardial Infarction(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
Stent Thrombosis(at 24 Hours, at 1 Month, at 1 Year)
Number of Participants With Procedure Success(at Hospital Discharge an average of 1 day)
All-cause Death(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
Number of Lesions With Device Success(at Hospital Discharge an average of 1 day)
Target Lesion Revascularization (TLR)(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
Target Vessel Revascularization (TVR)(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
Cardiac Death or Protocol-defined Any-vessel MI(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR(at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year)
Number of Lesions With Lesion Success(at Hospital Discharge an average of 1 day)