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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.
This is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the United States with subjects who undergo HF-OCT imaging as part of their cardiac catheterization procedure. This study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. The operator evaluation will be determined post use of the device using a Likert Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured by an independent core lab. Safety will be monitored through the interventional procedure and Adverse Events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance Endpoint | Clinical performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting as determined by the clinical operator using a Likert Grading Scale (1-5 scale; 1=unacceptable, 5= excellent) for each of the 4 measures [Catheter preparation, Catheter deliverability, Image Quality, Overall performance]. | During percutaneous interventional procedure, up to 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint: Incidence of Adverse Events | Incident Rate based on # of Adverse Events that are potentially related to either the device or the procedure for all 65 pullbacks on 32 participants. | During percutaneous interventional procedure, up to 2 hours. |
Inclusion Criteria:
Exclusion Criteria:
The lesion-specific exclusion criteria assessed from angiography are:
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Patients in the cardiac catheterization lab who are candidates for PCI
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States | ||
| St. Francis Hospital and Heart Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28663854 | Result | Swanson EA, Fujimoto JG. The ecosystem that powered the translation of OCT from fundamental research to clinical and commercial impact [Invited]. Biomed Opt Express. 2017 Feb 21;8(3):1638-1664. doi: 10.1364/BOE.8.001638. eCollection 2017 Mar 1. | |
| 26992420 | Result | van der Sijde JN, Karanasos A, van Ditzhuijzen NS, Okamura T, van Geuns RJ, Valgimigli M, Ligthart JM, Witberg KT, Wemelsfelder S, Fam JM, Zhang B, Diletti R, de Jaegere PP, van Mieghem NM, van Soest G, Zijlstra F, van Domburg RT, Regar E. Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound. Eur Heart J Cardiovasc Imaging. 2017 Apr 1;18(4):467-474. doi: 10.1093/ehjci/jew037. |
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A total of 90 subjects consented of which 56 were screen failures as a result of not meeting inclusion/exclusion criteria. Of the remaining 34 enrolled, 32 subjects completed the HF-OCT (High Frequency Optical Coherence Tomography) imaging. The remaining two subjects met all inclusion/exclusion and lesion specific criteria, however could not be imaged due to catheter malfunctions prior to HF-OCT Imaging. These two subjects were categorized as "Enrolled-not completed".
Prospective, Single Group, Unblinded, Multicenter
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| ID | Title | Description |
|---|---|---|
| FG000 | HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation | Primary Endpoint (Technical Performance): Clear Image Length Evaluation Secondary Endpoint (Clinical Performance) : Evaluation of 4 clinical performance categories using the 5 point Likert scale [Catheter Preparation, Deliverability, Image Quality, Overall Performance] Safety Endpoint: Incident Rate for imaging procedure related 'adverse events' observed in the complete study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All comers scheduled for a visit to the cardiac catheterization laboratory for a potential standard of care Percutaneous coronary intervention procedure treatment and met the inclusion/exclusion criteria were recruited.
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| ID | Title | Description |
|---|---|---|
| BG000 | HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation | Primary Endpoint (Technical Performance): Clear Image Length Evaluation Secondary Endpoint (Clinical Performance) : Evaluation of 4 clinical performance categories using the 5 point Likert scale [Catheter Preparation, Deliverability, Image Quality, Overall Performance] Safety Endpoint: Incident Rate for imaging procedure related 'adverse events' observed in the complete study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Participants were identified as male or female in the case report form. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technical Performance | Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure | An average of approximately 2.0 pullbacks per participant resulted in images gathered from 65 pullbacks in 32 participants. | Posted | Median | 95% Confidence Interval | millimeters | During percutaneous interventional procedure, up to 2 hours | Pullbacks | Pullbacks |
|
|
Adverse event data were collected during the procedure and up to 1 day following the procedure.
The investigator [Surgeon] performing the Percutaneous Coronary Intervention [ PCI] monitored the participant for any adverse events and documented it on the case report form if applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation | Primary Endpoint (Technical Performance): Clear Image Length Evaluation Secondary Endpoint (Clinical Performance) : Evaluation of 4 clinical performance categories using the 5 point Likert scale [Catheter Preparation, Deliverability, Image Quality, Overall Performance] Safety Endpoint: Incident Rate for imaging procedure related 'adverse events' observed in the complete study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphasia (post procedure) | Blood and lymphatic system disorders | Non-systematic Assessment | One subject developed aphasia post procedure (not related to procedure or device), due to a history of intra-cranial aneurysm and associated coiling in 2012. Subject was treated during procedure and discharged next day after CT scan. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajesh Kasbekar , Vice-President, Regulatory, Clinical and Quality | Gentuity, LLC | 7744151484 | rkasbekar@gentuity.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2024 | Jan 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Roslyn |
| New York |
| 11576 |
| United States |
| Lindner Research Center at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| 29020300 | Result | D'Ascenzo F, Iannaccone M, Saint-Hilary G, Bertaina M, Schulz-Schupke S, Wahn Lee C, Chieffo A, Helft G, Gili S, Barbero U, Biondi Zoccai G, Moretti C, Ugo F, D'Amico M, Garbo R, Stone G, Rettegno S, Omede P, Conrotto F, Templin C, Colombo A, Park SJ, Kastrati A, Hildick-Smith D, Gasparini M, Gaita F. 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. Eur Heart J. 2017 Nov 7;38(42):3160-3172. doi: 10.1093/eurheartj/ehx437. |
| 17515704 | Result | Dilmanian H, Aronow WS, Mundia M, Pucillo AL, Weiss MB, Kalapatapu K, Monsen CE. 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. 2007 May-Jun;14(3):277-9. doi: 10.1097/MJT.0b013e3180653377. |
| Result | Al-Sunduqchi, M. S. Determining the Appropriate Sample Size for Inferences Based on the Wilcoxon Statistics. (University of Wyoming. Department of Statistics, 1990). |
| 22562913 | Result | Yoon JH, Di Vito L, Moses JW, Fearon WF, Yeung AC, Zhang S, Bezerra HG, Costa MA, Jang IK. Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study. J Invasive Cardiol. 2012 May;24(5):206-9. |
The male and female count adds up to the overall count.
| Count of Participants |
| Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | This was a multicenter study conducted in 3 regions in the US: Illinois (11) , Ohio (14) and New York (7) | This number of participants is for the participants recruited in Advocate Hospital in Illinois, Christ Hospital in Ohio and St.Francis Hospital in New York respectively. | Number | Participants |
|
| Diabetes demographic | This measure identifies the number of participants that had diabetes | This identifies the number of participants of the overall number that had diabetes. | Number | Participants |
|
| Age, Continuous | This provides the mean and dispersion of the age of the participants who varied from 47 to 94 years of age. | Mean | Standard Deviation | Years |
|
| Participants |
|
| Pullbacks |
|
|
|
| Secondary | Clinical Performance Endpoint | Clinical performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting as determined by the clinical operator using a Likert Grading Scale (1-5 scale; 1=unacceptable, 5= excellent) for each of the 4 measures [Catheter preparation, Catheter deliverability, Image Quality, Overall performance]. | Each participant can have from 0 to 5 pullback to get the HF-OCT image from each pullback. An average of 2 pullbacks per participant yielded a total of 65 pullbacks for 32 participants. The acceptance criteria was that the mean Likert score for each of the 4 measures [Catheter preparation, Catheter deliverability, Image Quality, Overall performance] is greater than 3 for all pullbacks. | Posted | Mean | Standard Deviation | score on a scale | During percutaneous interventional procedure, up to 2 hours. | Pullbacks | Pullbacks |
|
|
|
|
| Other Pre-specified | Safety Endpoint: Incidence of Adverse Events | Incident Rate based on # of Adverse Events that are potentially related to either the device or the procedure for all 65 pullbacks on 32 participants. | Each participant can have 0 to 5 pullbacks to get the HF-OCT image. An average of 2 pullbacks per participant resulted in a total of 65 pullbacks. | Posted | Number | participants | During percutaneous interventional procedure, up to 2 hours. | Pullbacks | Pullbacks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 1 |
| 32 |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Title | Measurements |
|---|---|
|
| Mean overall performance |
|