NCT07491107Recruiting
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
National Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 30 Oct 2030
- Lead sponsor
- Scitech Produtos Medicos SA
- Diseases
- Coronary artery disease
- NCT number
- NCT07491107
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 30 Oct 2026 to the primary completion date, 30 Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to the use of a drug-eluting stent.
Other
- Lesions in saphenous vein grafts or internal mammary grafts.
- Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.