Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-02 @ 6:55 AM
Study NCT ID:
NCT05848232
Status:
UNKNOWN
Last Update Posted:
2024-05-10
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions
Sponsor:
ReFlow Medical, Inc.
Organization:
Study Overview
Official Title:
A Prospective Single-Arm Multicenter Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cora CTO
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: