The 3D Stent Study

CoreAalst

Status: Enrolling

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)

Treatments: Diagnostic Test: 3DStent

Study type: Observational

Funder types: Industry

Identifiers

NCT06898021

CA-1013

Details and patient eligibility

About

The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention.

The main question it aims to answer is:

The study hypothesis is that 3DStent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.

Exclusion criteria

1. Age <18 years
2. Coronary lesions requiring total stent length > 48 mm.
3. Body mass index >35 kg/m2
4. Uncontrolled recurrent ventricular tachycardia
5. Cardiogenic shock
6. Unable to provide written informed consent (IC).

Trial design

200 participants in 1 patient group

Patients undergoing PCI

Description:

Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI

Treatment:

Diagnostic Test: 3DStent