Back to resultsOCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation (Laranjeiras)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Sirolimus Eluting Stent Inspiron
Bare Metal Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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.
Sites / Locations
- Instituto Nacional de Cardiologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inspiron
Cronus
Arm Description
Sirolimus Eluting Stent Inspiron
Bare Metal Stent
Outcomes
Primary Outcome Measures
Safety
Percentage of strut coverage by OCT
Secondary Outcome Measures
Full Information
NCT ID
NCT02504307
First Posted
July 20, 2015
Last Updated
August 13, 2018
Sponsor
Scitech Produtos Medicos Ltda
1. Study Identification
Unique Protocol Identification Number
NCT02504307
Brief Title
OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation
Acronym
Laranjeiras
Official Title
Randomized Evaluation of Vascular Healing After Implantation of Sirolimus Eluting Stent Inspiron™ Versus Its Own Bare Metal Version- An OCT Evaluation After 3 Months Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scitech Produtos Medicos Ltda
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiron
Arm Type
Experimental
Arm Description
Sirolimus Eluting Stent Inspiron
Arm Title
Cronus
Arm Type
Active Comparator
Arm Description
Bare Metal Stent
Intervention Type
Device
Intervention Name(s)
Sirolimus Eluting Stent Inspiron
Intervention Description
Angioplasty with Sirolimus Eluting Stent Inspiron implantation
Intervention Type
Device
Intervention Name(s)
Bare Metal Stent
Intervention Description
Angioplasty with Bare Metal Stent Cronus implantation
Primary Outcome Measure Information:
Title
Safety
Description
Percentage of strut coverage by OCT
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Leandro, MD
Organizational Affiliation
Insituto Nacional de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cardiologia
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation
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