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.
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.
Eligibility
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.
