NCT02504307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 14, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

July 20, 2015

Last Update Submit

August 13, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Safety

    Percentage of strut coverage by OCT

    3 months

Study Arms (2)

Inspiron

EXPERIMENTAL

Sirolimus Eluting Stent Inspiron

Device: Sirolimus Eluting Stent Inspiron

Cronus

ACTIVE COMPARATOR

Bare Metal Stent

Device: Bare Metal Stent

Interventions

Sirolimus Eluting Stent InspironDEVICE

Angioplasty with Sirolimus Eluting Stent Inspiron implantation

Inspiron
Bare Metal StentDEVICE

Angioplasty with Bare Metal Stent Cronus implantation

Cronus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • MI within the last 72 hours
  • restenotic lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Sergio Leandro, MD

    Insituto Nacional de Cardiologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 21, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 14, 2018

Record last verified: 2018-03

Locations

BR(1)