INSPIRON Sirolimus Eluting Stent Performance in Bifurcati... | NCT03780192

Studies
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique

NCT03780192

Sponsor

Scitech Produtos Medicos SA

Status

Unknown status

Last Update Posted

Mar 17, 2020Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Bifurcation Lesion
Coronary Artery Disease

Interventions

Inspiron Sirolimus Eluting Stent

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2019Actual

Primary Completion Date

Feb 15, 2021Estimated

Completion Date

Feb 15, 2022Estimated

First Submitted Date

Dec 17, 2018

First Submission Date that Met QC Criteria

Dec 17, 2018

First Posted Date

Dec 19, 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

Mar 16, 2020

Last Update Posted Date

Mar 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marco Vugman Wainstein, Principal Investigator Hospital Moinhos de Vento, Scitech Produtos Medicos SAPrincipal Investigator

Lead Sponsor

Scitech Produtos Medicos SAINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.

Detailed Description

Not provided

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment		Bifurcation lesion treatment using provisional stent technique	Device: Inspiron Sirolimus Eluting Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inspiron Sirolimus Eluting Stent	Device	Bifurcation treatment using provisional stent technique	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Stenosis	% of stenosis on side branch after stent placement on main vessel	day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).

Exclusion Criteria:

Acute Myocardial Infarction (STMI);
Chronic occlusion;
Cardiogenic shock;
Ejection fraction ≤ 20%;
Thrombocytopenia (≤ 50 mil);
DAPT contraindication;
Life expectancy of less than 12 months.

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

All patients with bifurcation coronary artery disease with indication for drug eluting implantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marco Wainstein, MD	Contact	+555133143537		marco.wainstein@hmv.org.br

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Moinhos de Vento	Recruiting	Porto Alegre	Rio Grande do Sul		Brazil

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
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided