Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion

Coronary Artery Disease Clinical Trial

— OPEN-CTO  

Official title:

Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026466
• Other study ID #: OPEN CTO V1.2
• Status: Completed
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2021
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.

• Subject is = 18 years of age at the time of consent.

Exclusion Criteria:

• The CTO segment is in a graft

• Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.

• Non-English speaking

• Too hard of hearing to do follow-up by telephone.

• Previously enrolled in OPEN CTO Registry

• Currently a prisoner

• Dementia

• Subjects with no way contact by telephone for follow-up.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Presbyterian Health System Hospital	Albuquerque	New Mexico
United States	Boone Hospital Center	Columbia	Missouri
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Banner Heart Hospital	Mesa	Arizona
United States	Columbia University Medical Center	New York	New York
United States	Banner Good Samaritan	Phoenix	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Peace Health Sacred Heart River Bend Medical Center	Springfield	Oregon
United States	Torrance Memorial Medical Center	Torrance	California
United States	York Hospital	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Status	Quantify the baseline health status effects of CTO among patients selected for CTO-PCI and quantify the changes associated with CTO-PCI using the Hybrid Approach.	One year
Secondary	Safety and Effectiveness	Describe safety and effectiveness among patients receiving CTO-PCI	One Year