The 3D Stent Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-11

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease Percutaneous Coronary Intervention (PCI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing PCI

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

3DStent

Intervention Type DIAGNOSTIC_TEST

Coronary interventions will be performed according to the standard of care, which includes IVUS guidance. In patients undergoing stent implantation, a 3DStent image acquisition will be done followed by IVUS.

Interventions

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3DStent

Coronary interventions will be performed according to the standard of care, which includes IVUS guidance. In patients undergoing stent implantation, a 3DStent image acquisition will be done followed by IVUS.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No