Clinical trial NCT02026466: Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
Official title: Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Chronic Total Occlusion
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-01-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 or older with CAD and at least one chronic total occluded vessel.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health Status
timeFrame: One year
Secondary outcomes:
measure: Safety and Effectiveness
timeFrame: One Year
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan
state: Arizona
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Albuquerque
country: United States
facility: Presbyterian Health System Hospital
state: New Mexico
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Springfield
country: United States
facility: Peace Health Sacred Heart River Bend Medical Center
state: Oregon
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Saint Luke's Health System
name: J. Aaron Grantham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.
citation: Hirai T, Qintar M, Grantham JA, Sapontis J, Cohen DJ, Lombardi W, Karmpaliotis D, Moses J, Nicholson WJ, Nugent K, Gosch KL, Spertus JA, Salisbury AC. Patient Characteristics Associated With Antianginal Medication Escalation and De-Escalation Following Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Qual Outcomes. 2019 Jun;12(6):e005287. doi: 10.1161/CIRCOUTCOMES.118.005287. Epub 2019 Jun 12.
citation: Yeh RW, Tamez H, Secemsky EA, Grantham JA, Sapontis J, Spertus JA, Cohen DJ, Nicholson WJ, Gosch K, Jones PG, Valsdottir LR, Bruckel J, Lombardi WL, Jaffer FA. Depression and Angina Among Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention: The OPEN-CTO Registry. JACC Cardiovasc Interv. 2019 Apr 8;12(7):651-658. doi: 10.1016/j.jcin.2018.12.029. Epub 2019 Mar 13.