Percutaneous Coronary Intervention (PCI) involves positioning of a stent under Xray guidance to treat coronary arterial stenosis. It then requires intraprocedural assessment of stent positioning and deployment. Standard assessment is done using 2-dimensional angiography possibly augmented with stent enhancement algorithms (e.g. StentViz, GE HealthCare) and/or Intravascular Imaging such IVUS. IVUS brings excellent visualization and clinical information, but it is limited by catheter cost, workflow and time.
3D Stent Evaluation
3D Stent Evaluation
Coronary arteriosclerosis
All genders
18+
Recruiting now
Overview
Principal Investigator: Carey Kimmelstiel, MD
Contact Us
Jamie Rubinstein or Juan Carlos Collado Falcon
Study details
Inclusion Criteria
- 1) De novo clinically indicated for percutaneous coronary angioplasty
- 2) Presenting Proximal or mid vessel stenosis
- 3) Stenosis in native coronaries
4) Has a body mass index (BMI) less than 35 kg/m2
Exclusion Criteria
- 1. Minor subject
- 2. Pregnant woman
3. Unable to consent - 4. Presents acute ST-elevation myocardial infarction (MI) or any circumstance deemed by the Investigator as an emergency procedure For whom the Cumulated Radiation dose at time of 3D stent acquisition > 2500 mGySubject consented in a competing trial
5. Stenosis to be treated is located in grafts
Study Requirements
Patients will be recruited for this study prior to standard heart catheterization (PCI). The study will only last duirng the PCI procedure where a 3D acquisition will be performed in addition to standard of care 2D fluoroscopy & angiography images and IVUS imaging. No patient follow up specific to this study will be needed after the procedure, and unless a patient asks to withdraw participation, no additional interaction with the patient is anticipated.