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
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