Coronary Artery DiseaseREPAIRNCT03269461
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
A study testing Angiography and Optical Coherence Tomography evaluations in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 5 sites in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angiography and Optical Coherence Tomography evaluations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesBrazil
- Study dates
- 2 Oct 2017to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Hospital do Coração Anis Rassi
Goiânia, Goiás
Paraná Medical Research Center
Maringá, Paraná
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo
Hospital Evangélico do Espírito Santo
Vila Velha, Espírito Santo
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Angiography and Optical Coherence Tomography evaluations
- Keywords
- stent, DES, INSPIRON, OCT, tissue repair
- Medical subject headings
- Coronary Artery Disease, Dysequilibrium syndrome, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography and Optical Coherence Tomography evaluationsDevice
coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
| Study group | Role | What they receive |
|---|---|---|
| 30 days evaluation | Experimental | Angiography and Optical Coherence Tomography evaluations Receives: Device: Angiography and Optical Coherence Tomography evaluations |
| 2 months evaluation | Experimental | Angiography and Optical Coherence Tomography evaluations Receives: Device: Angiography and Optical Coherence Tomography evaluations |
| 3 months evaluation | Experimental | Angiography and Optical Coherence Tomography evaluations Receives: Device: Angiography and Optical Coherence Tomography evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Coverage
Change in the tissue coverage percentage measured by OCT
Measured: 3 months
Secondary outcomes (3)
in-stent late lumen loss
in-stent late lumen loss
Measured: 3 months
Stent Thrombosis
Stent Thrombosis Rates
Measured: 2 years
Target Vessel Failure
Target Vessel Failure (Death, MI and new revascularization)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start2 Oct 2017
- Primary completion30 Dec 2018
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269461
- Sponsor's protocol ID
- REPAIR
- Acronym
- REPAIR
- Status last verified
- Sep 2020
- First submitted
- 24 Aug 2017
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT03269461
- Acronym / sponsor ID
- REPAIR / REPAIR
- Conditions
- Coronary Artery Disease
- Keywords
- stent, DES, INSPIRON, OCT, tissue repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 days evaluation | Experimental | Device: Angiography and Optical Coherence Tomography evaluationsAngiography and Optical Coherence Tomography evaluations |
| 2 months evaluation | Experimental | Device: Angiography and Optical Coherence Tomography evaluationsAngiography and Optical Coherence Tomography evaluations |
| 3 months evaluation | Experimental | Device: Angiography and Optical Coherence Tomography evaluationsAngiography and Optical Coherence Tomography evaluations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- STEMI within the last 72 hours pre-procedure;
- renal insufficiency;
- Left Main stenosis > 50%;
- Ostial lesions;
- Bifurcation lesions with side branch ≥2mm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiography and Optical Coherence Tomography evaluationscoronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations | Device | 2 months evaluation, 3 months evaluation, 30 days evaluation |
Primary outcome
Tissue Coverage
Time frame: 3 months
Change in the tissue coverage percentage measured by OCT
3 secondary outcomes
in-stent late lumen loss
Time frame: 3 months
Stent Thrombosis
Time frame: 2 years
Target Vessel Failure
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography and Optical Coherence Tomography evaluations in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Coverage (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.