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

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Conditions studied: Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Complex Coronary Lesions

In brief

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.

Key facts

Study ID

NCT07491107

Run by

Scitech Produtos Medicos SA

People needed

2000

Starts

2026-04-30

Expected to finish

2030-04-30

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS) — Porto Alegre, Rio Grande do Sul, Brazil

Full record on ClinicalTrials.gov

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