NCT05848232

Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions

A Prospective Single-Arm Multicenter Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: ReFlow Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries. The study will compare the rate of procedure success to success rates from previous trials. Participants will undergo percutaneous coronary intervention (PCI) for a chronic total occlusion and be followed for 30 days post-procedure.

Detailed description

The primary objective of this prospective, multicenter, single arm clinical study is to compare the rate of procedure success of the coraCross, coraForce, and coraFlex catheters in facilitating guidewire placement beyond coronary chronic total occlusions to a pre-defined performance goal based on literature. The study population will consist of those 18 years or older with symptomatic ischemic heart disease, undergoing clinically indicated percutaneous recanalization of an occlusive coronary lesion, and meeting all other eligibility criteria. Measures will be assessed through 30 days post-intervention.

Conditions

• Coronary Occlusion

Interventions

Type	Name	Description
DEVICE	coraFlex Catheter	The coraFlex catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
DEVICE	coraForce Catheter	The coraForce catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
DEVICE	coraCross Catheter	The coraCross catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2023-05-08
• Last updated: 2024-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study