Coronary Artery Disease (CAD)PCI EVOlutionNCT07491107
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
An observational study of Coronary Artery Disease (CAD) and Stenosis Coronary, run by Scitech Produtos Medicos SA at 1 site in Brazil.
Trial summary
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease
- What is being tested?
- Inspiron EVO Drug-Eluting Stent
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Oct 2026to 30 Oct 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions treated with the Inspiron™ EVO Drug-Eluting Stent.
Who may be able to join
- Individuals aged 18 years or older presenting with complex coronary lesions requiring percutaneous coronary intervention (PCI).
- Individuals who provide consent and are willing to comply with the follow-up protocol.
- Individuals who received treatment with the Inspiron™ EVO Stent.
- Individuals with lesions ≥ 30 mm in length (Subprotocol 1).
- Individuals with significantly calcified coronary lesions (moderate to severe according to the ACC/AHA classification B1, B2, or C), with or without indication for lesion preparation techniques (Subprotocol 2).
- Individuals with multivessel coronary artery disease (≥2 affected coronary vessels, with at least one vessel of small diameter ≤2.5 mm) (Subprotocol 3).
- Individuals included in Subprotocol 1, 2, or 3. The evaluated segment must be accessible to the IVUS (Intravascular Ultrasound) catheter (Subprotocol 4).
Who cannot join
- Lesions in saphenous vein grafts or internal mammary grafts.
- Contraindication to the use of a drug-eluting stent.
- Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610000
Paulo Ricardo A Caramori, MD, +55 51 99982 0766, caramori@cardiarte.com.br
Rosa Homem, +55 51 99679 8040, cer.pesquisaclinica@gmail.com
About this study
Official title: National Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.
Read the detailed description
Post-marketing, observational, prospective, multi-center, non-randomized, single-arm registry that will include all patients who receive the Inspiron™ EVO stent at participating sites and meet the eligibility criteria.
Up to 2,000 patients are expected to be enrolled across 12 research sites in Brazil. Participants' demographic, procedural, and follow-up data will be collected for up to 12 months in this study.
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Complex Coronary Lesions
- Being tested
- Inspiron EVO Drug-Eluting Stent
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiron EVO Drug-Eluting StentDevice
Percutaneous coronary intervention (PCI) using the Inspiron EVO Drug-Eluting Stent, which has a reduced crimped profile, providing greater safety and facilitating lesion crossing. In addition, the design is optimized to provide increased radial strength.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Percutaneous coronary intervention (PCI) | Patients with symptomatic ischemic heart disease due to lesions in the native coronary artery and restenotic lesions treated with the Inspiron™ EVO drug-eluting stent. Receives: Device: Inspiron EVO Drug-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success
Device success (at the lesion level) is defined as the successful delivery, balloon expansion, and implantation of the first device at the target lesion (with multiple attempts using the same device permitted), successful withdrawal of the delivery system, and achievement of a final in-stent residual stenosis of <20%
Measured: Initial procedure
Acute Clinical Success of Percutaneous Coronary Intervention (PCI)
Defined as the absence of major adverse in-hospital cardiac events (death, myocardial infarction, or repeat coronary revascularization of the target lesion).
Measured: Up to 24 hours
MACE (Major Adverse Cardiac Events) rate
Defined as the combination of cardiac death, myocardial infarction (MI), or revascularization of the target lesion (TLR).
Measured: 12 months
Secondary outcomes (7)
Target Lesion Revascularization (TLR) rate
TLR is defined as any percutaneous reintervention of the target lesion, including the 5 mm proximal and 5 mm distal segments of the stent, or revascularization of the target vessel, performed for clinical reasons due to restenosis or occlusion of the target lesion.
Measured: 12 months
Target vessel revascularization rate (TVR)
TVR is defined as revascularization of any segment of the target coronary artery.
Measured: 12 months
Target Vessel Failure Rate (TVF)
Defined as a combination of MI, TLR, or cardiovascular death related to the target vessel. If it is not possible to determine with certainty whether the MI or death was related to the target vessel, the case is considered a TVF.
Measured: 12 months
Rate of definite, probable, and possible stent thrombosis (ST)
Stent thrombosis is classified as definite, probable, or possible: definite requires angiographic or pathological confirmation; probable includes unexplained death within 30 days or myocardial infarction related to the stented territory without angiographic confirmation; and possible refers to any unexplained death occurring from 30 days after implantation until the end of follow-up.
Measured: 12 months
Cardiovascular mortality
Any death due to an immediate cardiac cause (e.g., myocardial infarction, low-output heart failure, fatal arrhythmia), unwitnessed death, death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
Measured: 12 months
Late in-segment luminal loss (including the in-stent portion and the 5-mm proximal and distal edges)
Defined as the difference between the in-segment minimum luminal diameter (MLD) (including the in-stent portion and the 5-mm proximal and distal edges) after the procedure and the MLD at the 6-month follow-up, as determined by quantitative angiography.
Measured: 6 months
Percent Area Stenosis (%AS)
Defined as the ratio between the neointimal hyperplasia area and the stent area multiplied by 100 at the 6-month follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paulo Ricardo A Caramori, MD, Principal investigator, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491107
- Sponsor's protocol ID
- SCI-EV-001
- Acronym
- PCI EVOlution
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
- ClinicalTrials.gov ID
- NCT07491107
- Acronym / sponsor ID
- PCI EVOlution / SCI-EV-001
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Complex Coronary Lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2030 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 24 Mar 2026 (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.
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.
Detailed description
Post-marketing, observational, prospective, multi-center, non-randomized, single-arm registry that will include all patients who receive the Inspiron™ EVO stent at participating sites and meet the eligibility criteria.
Up to 2,000 patients are expected to be enrolled across 12 research sites in Brazil. Participants' demographic, procedural, and follow-up data will be collected for up to 12 months in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Percutaneous coronary intervention (PCI) | – | Device: Inspiron EVO Drug-Eluting StentPatients with symptomatic ischemic heart disease due to lesions in the native coronary artery and restenotic lesions treated with the Inspiron™ EVO drug-eluting stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions treated with the Inspiron™ EVO Drug-Eluting Stent.
Key inclusion criteria (7 listed)
- Individuals aged 18 years or older presenting with complex coronary lesions requiring percutaneous coronary intervention (PCI).
- Individuals who provide consent and are willing to comply with the follow-up protocol.
- Individuals who received treatment with the Inspiron™ EVO Stent.
- Individuals with lesions ≥ 30 mm in length (Subprotocol 1).
- Individuals with significantly calcified coronary lesions (moderate to severe according to the ACC/AHA classification B1, B2, or C), with or without indication for lesion preparation techniques (Subprotocol 2).
Key exclusion criteria (3 listed)
- Lesions in saphenous vein grafts or internal mammary grafts.
- Contraindication to the use of a drug-eluting stent.
- Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.
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 |
|---|---|---|
| Inspiron EVO Drug-Eluting StentPercutaneous coronary intervention (PCI) using the Inspiron EVO Drug-Eluting Stent, which has a reduced crimped profile, providing greater safety and facilitating lesion crossing. In addition, the design is optimized to provide increased radial strength. | Device | Experimental: Percutaneous coronary intervention (PCI) |
Primary outcome
Device success
Time frame: Initial procedure
Device success (at the lesion level) is defined as the successful delivery, balloon expansion, and implantation of the first device at the target lesion (with multiple attempts using the same device permitted), successful withdrawal of the delivery system, and achievement of a final in-stent residual stenosis of <20%
Acute Clinical Success of Percutaneous Coronary Intervention (PCI)
Time frame: Up to 24 hours
Defined as the absence of major adverse in-hospital cardiac events (death, myocardial infarction, or repeat coronary revascularization of the target lesion).
MACE (Major Adverse Cardiac Events) rate
Time frame: 12 months
Defined as the combination of cardiac death, myocardial infarction (MI), or revascularization of the target lesion (TLR).
7 secondary outcomes
Target Lesion Revascularization (TLR) rate
Time frame: 12 months
Target vessel revascularization rate (TVR)
Time frame: 12 months
Target Vessel Failure Rate (TVF)
Time frame: 12 months
Rate of definite, probable, and possible stent thrombosis (ST)
Time frame: 12 months
Cardiovascular mortality
Time frame: 12 months
Late in-segment luminal loss (including the in-stent portion and the 5-mm proximal and distal edges)
Time frame: 6 months
Percent Area Stenosis (%AS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- 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.
Paulo Ricardo A Caramori, MD principal investigator
Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) and Stenosis Coronary, run by Scitech Produtos Medicos SA at 1 site 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Aurélio A Costa, MD, PhD (+1 216 903-9327, marco.costa@scitechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success (time frame: Initial procedure). The study lists 3 primary outcomes in all. 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 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.