BIOFLOW-SV All Comers Registry | NCT03600948

Studies
BIOFLOW-SV All Comers Registry

NCT03600948

Sponsor

Biotronik AG

Status

Terminated

Last Update Posted

Feb 15, 2024Actual

Enrollment

261Actual

Phase

Not provided

Conditions

de Novo
Symptomatic Ischemic Heart Disease
Restenoses, Coronary

Interventions

Orsiro Sirolimus Eluting Coronary Stent System

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Problem with enrollment due to Covid-19

Expanded Access Info

Start Date

Aug 27, 2018Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Oct 6, 2021Actual

First Submitted Date

Jul 17, 2018

First Submission Date that Met QC Criteria

Jul 17, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2024

Last Update Posted Date

Feb 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

261Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orsiro Sirolimus Eluting Coronary Stent System	Device	Percutaneous coronary intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Target Lesion Failure for the small vessel group	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)	12 months

Secondary Outcomes

Measure	Description	Time Frame
TLF for the overall cohort	TLF at 12 months post procedure for the overall cohort	at 12 months
Clinically driven Target Lesion Revascularization (TLR)	Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Weinstain, MD	Moinhos de Vento Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Moinhos de Vento Hospital		Porto Alegre		90560-030	Brazil
Hospital de Base

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D023903	Coronary Restenosis

Ancestor Terms

ID	Term
D023921	Coronary Stenosis
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided