Vis-Rx Prime Micro-Imaging Catheter Study

NCT06685783 | Completed Results

• 1 other identifier: MISC-074
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

To study the performance of the Gentuity® HF-OCT (High Frequency Optical Coherence Tomography) Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. The study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. The patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Technical Performance

  Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure

  During percutaneous interventional procedure, up to 2 hours

Secondary Outcomes (1)

• Clinical Performance Endpoint

  During percutaneous interventional procedure, up to 2 hours.

Other Outcomes (1)

• Safety Endpoint: Incidence of Adverse Events

  During percutaneous interventional procedure, up to 2 hours.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the cardiac catheterization lab who are candidates for PCI

You may qualify if:

• Patients 18 years of age or older
• Patients willing and able to provide written informed consent to participate in evaluation
• Patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as PCI)

You may not qualify if:

• Bacteremia or sepsis
• Major coagulation system abnormalities
• Severe hemodynamic instability or shock
• Acute renal failure
• Disqualified for Coronary Artery Bypass Graft surgery
• Disqualified for Percutaneous Coronary Intervention
• Patients currently enrolled in another study to evaluate an investigational device or medication
• Any target vessel which has undergone a bypass procedure
• Total occlusion
• Coronary artery spasm
• Large thrombus (as visible under angiography)

Sponsors & Collaborators

• Gentuity, LLC: lead

Study Sites (3)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

St. Francis Hospital and Heart Center

Roslyn, New York, 11576, United States

Location

Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (6)

• Swanson, E. A. & Fujimoto, J. G. The ecosystem that powered the translation of OCT from fundamental research to clinical and commercial impact [Invited]. Biomedical optics express 8, 1638-1664, doi:10.1364/BOE.8.001638 (2017).

  RESULT

• van der Sijde, J. N. et al. Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound. European heart journal cardiovascular Imaging 18, 467-474, doi:10.1093/ehjci/jew037 (2017).

  RESULT

• D'Ascenzo, F. et al. Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients. European heart journal 38, 3160-3172, doi:10.1093/eurheartj/ehx437 (2017).

  RESULT

• Dilmanian, H. et al. The average stent length is longer and the average stent diameter is shorter in patients with drug-eluting stents versus bare-metal stents during percutaneous coronary intervention. Am J Ther 14, 277-279, doi:10.1097/MJT.0b013e3180653377 (2007).

  RESULT

• Al-Sunduqchi, M. S. Determining the Appropriate Sample Size for Inferences Based on the Wilcoxon Statistics. (University of Wyoming. Department of Statistics, 1990).

  RESULT

• Yoon, J. H. et al. Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study. The Journal of invasive cardiology 24, 206-209 (2012).

  RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

There were no limitations or technical problems with data collection. A total of 90 subjects were consented of which 56 subjects were screen failures. Of the remaining 34, 32 had the HF-OCT Imaging completed with a total of 65 pullbacks. This met the powered sample size requirement of over 38 pullbacks. The remaining 2 participants were enrolled but excluded due to a device and procedure related issue respectively.

Results Point of Contact

• Title: Dr. Rajesh Kasbekar , Vice-President, Regulatory, Clinical and Quality
• Organization: Gentuity, LLC

rkasbekar@gentuity.com

7744151484

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 11, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 1, 2025
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-04

Locations

US (3)