Latin America Real World Study With Inspiron Drug Eluting... | NCT03471234

Studies
Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE

NCT03471234

Sponsor

Scitech Produtos Medicos SA

Status

Completed

Last Update Posted

May 18, 2023Actual

Enrollment

299Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Angioplasty

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2018Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Aug 2, 2022Actual

First Submitted Date

Mar 5, 2018

First Submission Date that Met QC Criteria

Mar 19, 2018

First Posted Date

Mar 20, 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

May 17, 2023

Last Update Posted Date

May 18, 2023Actual

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

Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Detailed Description

Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

299Actual

Name	Type	Description	Arm Group Labels	Other Names
Angioplasty	Device	Inspiron Drug Eluting stent implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE (major cardiac events)	Major cardiac events (death, myocardial infarction, target vessel revascularization)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Acute success	Acute success measured by Angiography after stent implantation	up to 24 hours
Stent Thrombosis	Stent Thrombosis rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

Exclusion Criteria:

Saphenous vein grafts or Mammary lesions;
Individuals who have been treated within the last 6 months with another stent;
Acute myocardial infarction with ST segment elevation;
Chronic Total Occlusion

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

Patients with lesions in native coronary arteries measuring between 2.5 and 4.0 mm in diameter and 34 mm length treated only with Inspiron Sirolimus-Eluting Stent.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Dante Pazzanese de Cardiologia		São Paulo			Brazil
Instituto do Coração - INCOR

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
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017130	Angioplasty

Ancestor Terms

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided