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Not yet recruiting NCT07491107

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

— Observational Coronary Artery Disease (CAD) Stenosis Coronary Small Vessel Ischemic Disease Multivessel Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspiron EVO Drug-Eluting Stent.
Who it may be relevant to
Registry conditions: Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Device success [Time frame: Initial procedure]
  • Acute Clinical Success of Percutaneous Coronary Intervention (PCI) [Time frame: Up to 24 hours]
  • MACE (Major Adverse Cardiac Events) rate [Time frame: 12 months]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS) — Porto Alegre

Identifiers

NCT: NCT07491107 · SCI-EV-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗