NCT04710342

Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions

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

• 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

This study represents a prospective, non-randomized, dual-center clinical study to evaluate the safety and effectiveness of the CapBuster System in crossing a de novo or restenotic infrapopliteal chronic total occlusion. Measures of safety and efficacy will be assessed through 30 days post-intervention.

Detailed description

The diagnostic and interventional procedure can be conducted via contralateral or antegrade approach and arterial access will be obtained utilizing standard percutaneous techniques and devices. Baseline angiographic images will be obtained prior to the study intervention to confirm the presence of a peripheral arterial occlusion. These images will include the target lesion as well as inflow and outflow with ipsilateral run off to the distal foot. If angiographic imaging confirms that the subject meets enrollment criteria, the enrolled subject will then undergo the study procedure. If the investigator determines that treatment is required of non-target arterial lesions, the treatment may be performed during the study index procedure according to the investigator's standard practices using commercially available devices. Prior to utilization of the CapBuster system, the investigator will attempt to cross the target lesion CTO utilizing conventional catheters and guidewires. To minimize vessel trauma, attempted guidewire crossing time will be limited to no more than 5 minutes. The crossing time will begin when the guidewire reaches the lesion CTO cap and will end after occlusion is successfully crossed with confirmed wire placement in the true lumen. If successful crossing is achieved with a conventional guidewire, the CapBuster system will not be utilized. The subject will be a screen failure and will not be considered enrolled in the trial. If crossing attempt is not successful with a conventional guidewire, the CapBuster system will be utilized. A subject is considered enrolled in the study upon introduction of the CapBuster system into the subject's vasculature. The CapBuster support catheter will be inserted over a conventional guidewire and advanced until the distal tip reaches the CTO cap. The CapBuster 3.0 mm diameter balloon is then inflated to stabilize the system within the arterial vessel. The conventional guidewire is replaced with the CapBuster penetrating wire and, under fluoroscopic guidance, the penetrating wire is manually rotated to penetrate the CTO cap. The balloon pressure may be increased to ensure proper apposition with the vessel wall and maximize stability. Following penetration of the cap, the penetrating wire is replaced with a conventional steerable guidewire. Standard wire escalation techniques will be utilized for continued advancement of the conventional guidewire and complete crossing of the occlusion. Angiography is performed to confirm guidewire placement. Successful crossing is defined as guidewire placement within the true lumen proximal and distal to the target lesion without utilization of a re-entry device. After successful crossing is achieved, the target lesion may be treated per Investigator discretion with commercially available devices.

Conditions

• Chronic Total Occlusion

Interventions

Type	Name	Description
DEVICE	CapBuster	Evaluate the safety and effectiveness of the CapBuster System in crossing de novo or restenotic chronic total occlusions in infrapopliteal peripheral arteries.

Timeline

• Start date: 2021-06-21
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-01-14
• Last updated: 2023-02-21

Locations

1 site across 1 country: Netherlands