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Evaluating the Use of the CapBuster System for the Crossing of CTO's in Coronary Arteries

Chronic Total Occlusion of Coronary Artery Clinical Trial

Official title:
A Non-Randomized Clinical Study Evaluating Use of the CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries

Clinical Trial Summary

Evaluate the safety and effectiveness of the CapBuster System medical device in crossing de novo or restenotic chronic total occlusions in coronary arteries

Clinical Trial Description

Primary Efficacy Endpoints: Successful crossing of the targeted chronic total occlusion, defined as angiography confirmed guidewire placement in the true lumen without utilization of a re-entry device. The effectiveness endpoint is designed to demonstrate successful crossing of the chronic total occlusion in at least 80% of lesions. Primary Safety Endpoints: Freedom from CapBuster System related clinically significant perforation, embolization, or dissection, defined as perforations or embolization that require intervention and flow-limiting (type C, D, E) dissections. Secondary Endpoints I. Study procedure success, defined as successful CTO crossing with the absence of in-hospital/outpatient lab significant events and clinically significant perforation, embolization, or dissection not resolved by visual estimate. II. Evaluation of CTO crossing time. III. Evaluation of total procedural time, fluoroscopic time, and contrast volume. IV. All CapBuster System related adverse events through 30 days post-procedure. V. Lesion treatment success, defined as ≤ 30% final residual stenosis of the target lesion using commercially available percutaneous treatment modalities. VI. Freedom from CapBuster System related significant events through 30 days, defined as death or target vessel revascularization that occurred as a result of a CapBuster System related complication or adverse event. ;

Study Design

Related Conditions & MeSH terms

  • Chronic Total Occlusion of Coronary Artery
Clinical Trial Details
NCT number NCT05733481
Study type Interventional
Source Praxis Medical Devices Ltd
Contact
Status Not yet recruiting
Phase N/A
Start date April 1, 2023
Completion date December 31, 2024
View Details
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