Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-04-27
Brief Title:
Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions
Sponsor:
ReFlow Medical Inc
Organization:
ReFlow Medical Inc
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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?:
None