Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-28 @ 8:12 AM
Study NCT ID:
NCT02026466
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
Sponsor:
Saint Luke's Health System
Organization:
Study Overview
Official Title:
Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
Status:
COMPLETED
Status Verified Date:
2021-10
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:
OPEN-CTO
Brief Summary:
This is an observational registry, sponsored by Saint Luke's Hospital. This study is to be conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies and procedures. The overall objective is to address current gaps in knowledge regarding CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.
Detailed Description:
* 1,000 participants will be enrolled into the OPEN CTO study.
* Study coordinators will screen both men and women over the age of 18 who are admitted for an elective CTO-PCI procedure.
* Study coordinators will be trained by the Coordinating Center at Saint Luke's Hospital of Kansas City.
* Participants will be screened for Eligibility, and Informed Consent will be obtained.
* Participants will also be asked to sign a Medical Records Release form, and a Billing Records Release form.
* Detailed procedural data will be obtained by the Study Coordinator and local Principal Investigator.
* Participants will undergo a Baseline interview.
* These data will be entered into the electronic data capture system, Velos, which has stringent protections and quality controls.
* Participants will have telephone follow-up interviews conducted by the centralized Follow-up Center at Saint Luke's Hospital.
* Study coordinators will screen both men and women over the age of 18 who are admitted for an elective CTO-PCI procedure.
* Study coordinators will be trained by the Coordinating Center at Saint Luke's Hospital of Kansas City.
* Participants will be screened for Eligibility, and Informed Consent will be obtained.
* Participants will also be asked to sign a Medical Records Release form, and a Billing Records Release form.
* Detailed procedural data will be obtained by the Study Coordinator and local Principal Investigator.
* Participants will undergo a Baseline interview.
* These data will be entered into the electronic data capture system, Velos, which has stringent protections and quality controls.
* Participants will have telephone follow-up interviews conducted by the centralized Follow-up Center at Saint Luke's Hospital.
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?: