Inspiron EVO stent in complex coronary lesions in Brazil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-marketing, observational registry that enrolls all eligible patients receiving the Inspiron EVO stent across multiple Brazilian centers. It is non-randomized and single-arm, collecting demographic, procedural, and follow-up data for up to 12 months. The goal is to observe outcomes in patients with complex lesions, including long lesions, heavy calcification, and multivessel disease, to understand safety and effectiveness in routine practice. Enrollment aims for up to 2,000 participants at 12 sites, with IVUS guidance considered for eligible segments where applicable.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Paulo Ricardo A Caramori, MD — Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
• Study coordinator: Marco Aurélio A Costa, MD, PhD
• Email: marco.costa@scitechmed.com
• Phone: +1 216 903-9327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.