Post-marketing Registry of Inspiron Sirolimus Eluting Cor... | NCT03263260

Studies
Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

NCT03263260

Sponsor

Scitech Produtos Medicos SA

Status

Completed

Last Update Posted

Sep 4, 2024Actual

Enrollment

2,504Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

implant

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

Sep 2024

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

Jun 2, 2017Actual

Primary Completion Date

Dec 15, 2022Actual

Completion Date

Jan 21, 2024Actual

First Submitted Date

Aug 24, 2017

First Submission Date that Met QC Criteria

Aug 24, 2017

First Posted Date

Aug 28, 2017Actual

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

Sep 2, 2024

Last Update Posted Date

Sep 4, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.

Detailed Description

Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.

Stent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure.

Patients will be followed at 30 days, 1 and 2 years after procedure.

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

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,504Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
implanted patients		Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent	Device: implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
implant	Device	coronary stent implantation	implanted patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac Events Rate	Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis	12 months

Secondary Outcomes

Measure	Description	Time Frame
Target Vessel and Lesion Revascularization Rates	Target Vessel and Lesion Revascularization	24 months
Stent Thrombosis Rate	Stent Thrombosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years

Exclusion Criteria:

Safein Vein or Left Internal Mammary artery Grafts

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 older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS		Porto Alegre	Rio Grande do Sul	90.619-900	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
C535731	Dysequilibrium syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016254	Mutagenesis, Insertional

Ancestor Terms

ID	Term
D015202	Protein Engineering
D005818	Genetic Engineering
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided