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Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation (REPAIR)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Angiography and Optical Coherence Tomography evaluations
Sponsored by
Scitech Produtos Medicos Ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring stent, DES, INSPIRON, OCT, tissue repair

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 and ≤ 80years;
  • Symptomatic CAD or documented myocardial ischemic disease;
  • Up to 2 de novo lesions on native coronary arteries;
  • Lesion length ≤ 29mm;
  • Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;
  • Stenose at target lesion ≥ 70% and ≤ 99%.

Exclusion Criteria:

  • STEMI within the last 72 hours pre-procedure;
  • renal insufficiency;
  • Left Main stenosis > 50%;
  • Ostial lesions;
  • Bifurcation lesions with side branch ≥2mm;
  • More than one lesion > 50% at the target vessel;
  • Left Ejection Fraction less than 30%;
  • Previous (less than 6 months) PCI at the target vessel.

Sites / Locations

  • Hospital Evangélico do Espírito Santo
  • Hospital do Coração Anis Rassi
  • Paraná Medical Research Center
  • Instituto de Cardiologia do Rio Grande do Sul
  • Instituto Dante Pazzanese de Cardiologia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

30 days evaluation

2 months evaluation

3 months evaluation

Arm Description

Angiography and Optical Coherence Tomography evaluations

Angiography and Optical Coherence Tomography evaluations

Angiography and Optical Coherence Tomography evaluations

Outcomes

Primary Outcome Measures

Tissue Coverage
Change in the tissue coverage percentage measured by OCT

Secondary Outcome Measures

in-stent late lumen loss
in-stent late lumen loss
Stent Thrombosis
Stent Thrombosis Rates
Target Vessel Failure
Target Vessel Failure (Death, MI and new revascularization)

Full Information

First Posted
August 24, 2017
Last Updated
September 3, 2020
Sponsor
Scitech Produtos Medicos Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT03269461
Brief Title
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Acronym
REPAIR
Official Title
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scitech Produtos Medicos Ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.
Detailed Description
The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days. All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
stent, DES, INSPIRON, OCT, tissue repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 days evaluation
Arm Type
Experimental
Arm Description
Angiography and Optical Coherence Tomography evaluations
Arm Title
2 months evaluation
Arm Type
Experimental
Arm Description
Angiography and Optical Coherence Tomography evaluations
Arm Title
3 months evaluation
Arm Type
Experimental
Arm Description
Angiography and Optical Coherence Tomography evaluations
Intervention Type
Device
Intervention Name(s)
Angiography and Optical Coherence Tomography evaluations
Intervention Description
coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
Primary Outcome Measure Information:
Title
Tissue Coverage
Description
Change in the tissue coverage percentage measured by OCT
Time Frame
3 months
Secondary Outcome Measure Information:
Title
in-stent late lumen loss
Description
in-stent late lumen loss
Time Frame
3 months
Title
Stent Thrombosis
Description
Stent Thrombosis Rates
Time Frame
2 years
Title
Target Vessel Failure
Description
Target Vessel Failure (Death, MI and new revascularization)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤ 80years; Symptomatic CAD or documented myocardial ischemic disease; Up to 2 de novo lesions on native coronary arteries; Lesion length ≤ 29mm; Reference vessel diameter between ≥2.5 and ≤ 3.5 mm; Stenose at target lesion ≥ 70% and ≤ 99%. Exclusion Criteria: STEMI within the last 72 hours pre-procedure; renal insufficiency; Left Main stenosis > 50%; Ostial lesions; Bifurcation lesions with side branch ≥2mm; More than one lesion > 50% at the target vessel; Left Ejection Fraction less than 30%; Previous (less than 6 months) PCI at the target vessel.
Facility Information:
Facility Name
Hospital Evangélico do Espírito Santo
City
Vila Velha
State/Province
Espírito Santo
Country
Brazil
Facility Name
Hospital do Coração Anis Rassi
City
Goiânia
State/Province
Goiás
Country
Brazil
Facility Name
Paraná Medical Research Center
City
Maringá
State/Province
Paraná
Country
Brazil
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

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