OCT Evaluation 3 Months After Sirolimus Eluting Stent Imp... | NCT02504307

Studies
OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

NCT02504307

Sponsor

Scitech Produtos Medicos SA

Status

Completed

Last Update Posted

Aug 14, 2018Actual

Enrollment

36Actual

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Sirolimus Eluting Stent Inspiron
Bare Metal 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 2018

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

Jul 2015

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Jul 20, 2015

First Submission Date that Met QC Criteria

Jul 20, 2015

First Posted Date

Jul 21, 2015Estimated

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

Aug 13, 2018

Last Update Posted Date

Aug 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inspiron	Experimental	Sirolimus Eluting Stent Inspiron	Device: Sirolimus Eluting Stent Inspiron
Cronus	Active Comparator	Bare Metal Stent	Device: Bare Metal Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sirolimus Eluting Stent Inspiron	Device	Angioplasty with Sirolimus Eluting Stent Inspiron implantation	Inspiron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	Percentage of strut coverage by OCT	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

one or two de novo lesions (> 50% visual estimation)
lesion diameter between 2.5 and 3.5 mm
lesion length up to 33 mm.

Exclusion Criteria:

MI within the last 72 hours
restenotic lesion.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergio Leandro, MD	Insituto Nacional de Cardiologia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Cardiologia		Rio de Janeiro	Rio de Janeiro		Brazil

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