ClinicalTrials.gg
CompletedNCT03269461REPAIRUpdated Sep 4, 2020

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

An interventional study of Angiography and Optical Coherence Tomography evaluations in Coronary Artery Disease, sponsored by Scitech Produtos Medicos Ltda. Completed at 5 sites in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Scitech Produtos Medicos Ltda · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 152 studies in Coronary Artery Disease with a site in Brazil — 22 open to participants now, 30 under way, 4 of them phase 3. Coronary Artery Disease · Brazil.

Enrollment
77th of 123
60 · median 100
Started
2017
with 10 others
No phase
67 of 152
14 open now
Registered
88th of 152
by date
Lead sponsor
9 of 152
Scitech Produtos Medicos Ltda

Among the 152 studies in Coronary Artery Disease with a site in Brazil, this one is the 77th largest by enrollment of the 123 interventional ones that give a count, is one of 11 that started in 2017, is one of 67 with no phase, and was the 88th registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

22 of the 152 studies in Coronary Artery Disease with a site in Brazil are open now. Recruiting first, the newest first:

17 more — sign in →

All 22 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

Read the 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.

03

Conditions studied

  • Coronary Artery Disease

Keywords

  • stent, DES, INSPIRON, OCT, tissue repair
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 less than 30%;
  • Previous (less than 6 months) PCI at the target vessel.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    30 days evaluation

    Angiography and Optical Coherence Tomography evaluations

    Device: Angiography and Optical Coherence Tomography evaluations

  • Experimental
    2 months evaluation

    Angiography and Optical Coherence Tomography evaluations

    Device: Angiography and Optical Coherence Tomography evaluations

  • Experimental
    3 months evaluation

    Angiography and Optical Coherence Tomography evaluations

    Device: Angiography and Optical Coherence Tomography evaluations

Interventions

  • DeviceAngiography and Optical Coherence Tomography evaluations

    coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

06

What researchers measure

Primary outcomes

  1. Tissue Coverage

    Change in the tissue coverage percentage measured by OCT

    Time frame: 3 months

Secondary outcomes

  1. in-stent late lumen loss

    in-stent late lumen loss

    Time frame: 3 months

  2. Stent Thrombosis

    Stent Thrombosis Rates

    Time frame: 2 years

  3. Target Vessel Failure

    Target Vessel Failure (Death, MI and new revascularization)

    Time frame: 2 years

07

Study locations

5 sites
  • Hospital Evangélico do Espírito Santo
    Vila Velha, Espírito Santo, Brazil
  • Hospital do Coração Anis Rassi
    Goiânia, Goiás, Brazil
  • Paraná Medical Research Center
    Maringá, Paraná, Brazil
  • Instituto de Cardiologia do Rio Grande do Sul
    Porto Alegre, Rio Grande Do Sul, Brazil
  • Instituto Dante Pazzanese de Cardiologia
    São Paulo, SP, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2018, 14 months.

Of 177 industry-sponsored interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 40. This study's 14 months is below that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2017
First posted
Aug 31, 2017
StartActual
Oct 2, 2017
Primary completionActual
Dec 30, 2018
CompletionActual
Aug 30, 2020
Last update
Sep 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03269461
Lead sponsor
Scitech Produtos Medicos Ltda
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Oct 2, 2017
Primary completion
Dec 30, 2018
Completion
Aug 30, 2020
Last update
Sep 4, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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