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

September 3, 2020 updated by: Scitech Produtos Medicos Ltda
Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Espírito Santo
      • Vila Velha, Espírito Santo, Brazil
        • Hospital Evangélico do Espírito Santo
    • Goiás
      • Goiânia, Goiás, Brazil
        • Hospital do Coração Anis Rassi
    • Paraná
      • Maringá, Paraná, Brazil
        • Parana Medical Research Center
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Instituto de Cardiologia do Rio Grande do Sul
    • SP
      • São Paulo, SP, Brazil
        • Instituto Dante Pazzanese de Cardiologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30 days evaluation
Angiography and Optical Coherence Tomography evaluations
Device: Angiography and Optical Coherence Tomography evaluations
coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
Experimental: 2 months evaluation
Angiography and Optical Coherence Tomography evaluations
Device: Angiography and Optical Coherence Tomography evaluations
coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
Experimental: 3 months evaluation
Angiography and Optical Coherence Tomography evaluations
Device: Angiography and Optical Coherence Tomography evaluations
coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Coverage
Time Frame: 3 months
Change in the tissue coverage percentage measured by OCT
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-stent late lumen loss
Time Frame: 3 months
in-stent late lumen loss
3 months
Stent Thrombosis
Time Frame: 2 years
Stent Thrombosis Rates
2 years
Target Vessel Failure
Time Frame: 2 years
Target Vessel Failure (Death, MI and new revascularization)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scitech Produtos Medicos Ltda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPAIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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