BIOFLOW-SV All Comers Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

261 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-27

Study Completion Date

2021-10-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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de Novo Symptomatic Ischemic Heart Disease Restenoses, Coronary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Orsiro Sirolimus Eluting Coronary Stent System

Percutaneous coronary intervention

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No