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

Recruitingn/aAges 18 Years - anyAllScitech Produtos Medicos SA
NCT07491107 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Inspiron EVO Drug-Eluting Stent
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Where

1 site
Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Porto Alegre, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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