Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-08 @ 4:25 AM
Study NCT ID:
NCT01978860
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
Sponsor:
Chanan Schneider
Organization:
Study Overview
Official Title:
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter in (CTO) Coronary Lesions
Status:
COMPLETED
Status Verified Date:
2015-10
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:
None
Brief Summary:
This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO penetration rate.
Each study subject/patient will have a total of one (1) procedure performed for this study.
Each study subject/patient will have a total of one (1) procedure performed for this study.
Detailed Description:
To be filled later
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HTA6696 | OTHER | Israeli Ministry of Health Department | View |