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

NCT07491107 | Not Yet Recruiting

• 1 other identifier: SCI-EV-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 stent.

Conditions

Coronary Artery Disease (CAD); Stenosis Coronary; Small Vessel Ischemic Disease; Multivessel Coronary Artery Disease; Calcific Coronary Arteriosclerosis; Complex Coronary Lesions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Target Lesion Revascularization (TLR) rate

  12 months

• Target vessel revascularization rate (TVR)

  12 months

• Target Vessel Failure Rate (TVF)

  12 months

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

  12 months

• Cardiovascular mortality

  12 months

Study Arms (1)

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

Interventions

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.

Experimental: Percutaneous coronary intervention (PCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scitech Produtos Medicos SA: lead

Study Sites (1)

Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Paulo Ricardo A Caramori, MD

  Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Aurélio A Costa, MD, PhD

CONTACT

+1 216 903-9327; marco.costa@scitechmed.com

Ana Paula B Pellaquim, MSc.

CONTACT

+55 62 9471-4439; aalmeida@scitechmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 24, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)