NCT05733481

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Praxis Medical Devices Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Total Occlusion of Coronary Artery

Interventions

Type	Name	Description
DEVICE	CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries	The CapBuster System is a medical device intended to facilitate the intraluminal placement of conventional guidewires beyond chronic total occlusions prior to the utilization of interventional devices. The device system, manufactured by Praxis Medical, comprises the CapBuster support catheter and CapBuster penetrating wire which are mated together with a screw thread.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-02-17
• Last updated: 2023-02-21