Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions (PCI EVOlution)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease (CAD); Multivessel Coronary Artery Disease; Complex Coronary Lesions; Calcific Coronary Arteriosclerosis; Small Vessel Ischemic Disease; Stenosis Coronary
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Marco Aurélio A Costa, MD, PhD; Phone Number: +1 216 903-9327; Email: marco.costa@scitechmed.com
• Study Contact Backup: Name: Ana Paula B Pellaquim, MSc.; Phone Number: +55 62 9471-4439; Email: aalmeida@scitechmed.com

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610000
      • Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
      • Contact: Paulo Ricardo A Caramori, MD; Phone Number: +55 51 99982 0766; Email: caramori@cardiarte.com.br
      • Contact: Rosa Homem; Phone Number: +55 51 99679 8040; Email: cer.pesquisaclinica@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Inspiron EVO Drug-Eluting Stent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	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).	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Target vessel revascularization rate (TVR)	TVR is defined as revascularization of any segment of the target coronary artery.	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.	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.	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos SA
• Investigators: Principal Investigator: Paulo Ricardo A Caramori, MD, Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: SCI-EV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No