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NCT Number: NCT07491107

Brazilian 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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Calcific Coronary Arteriosclerosis Cardiovascular Diseases Complex Coronary Lesions Coronary Artery Disease Coronary Disease Coronary Stenosis Heart Diseases Multivessel Coronary Artery Disease Myocardial Ischemia Small Vessel Ischemic Disease Stenosis Coronary Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Inspiron EVO Drug-Eluting Stent

Device

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.

Primary outcomes

  1. 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%

  2. 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).

  3. 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).

Secondary outcomes

  1. Target Lesion Revascularization (TLR) rate

    Time frame: 12 months

    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.

  2. Target vessel revascularization rate (TVR)

    Time frame: 12 months

    TVR is defined as revascularization of any segment of the target coronary artery.

  3. Target Vessel Failure Rate (TVF)

    Time frame: 12 months

    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.

  4. Rate of definite, probable, and possible stent thrombosis (ST)

    Time frame: 12 months

    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.

  5. Cardiovascular mortality

    Time frame: 12 months

    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.

  6. Late in-segment luminal loss (including the in-stent portion and the 5-mm proximal and distal edges)

    Time frame: 6 months

    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.

  7. Percent Area Stenosis (%AS)

    Time frame: 6 months

    Defined as the ratio between the neointimal hyperplasia area and the stent area multiplied by 100 at the 6-month follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Paula B Pellaquim, MSc.

CONTACT

[email protected]

+55 62 9471-4439

Marco Aurélio A Costa, MD, PhD

CONTACT

[email protected]

+1 216 903-9327

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Official study title

National Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions

Acronym: PCI EVOlution

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 24, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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