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

NCT05848232 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

  • Coronary Occlusion

Interventions

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.

Sponsors & Collaborators

  • ReFlow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Lorenzo Azzalini, MD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-01-31
Completion
2025-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848232 on ClinicalTrials.gov