NCT02026466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

November 26, 2013

Last Update Submit

October 14, 2021

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseChronic Total Occlusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety and Effectiveness

    One Year

Study Arms (1)

CAD with CTO

Subjects will have Coronary Artery Disease with a diagnosed Chronic Total Occlusion: a coronary artery with TIMI flow of zero(no flow) for at least three months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 or older with CAD and at least one chronic total occluded vessel.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Banner Heart Hospital

Mesa, Arizona, 85206, United States

Location

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Presbyterian Health System Hospital

Albuquerque, New Mexico, 87106, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Peace Health Sacred Heart River Bend Medical Center

Springfield, Oregon, 94777, United States

Location

York Hospital

York, Pennsylvania, 17405, United States

Location

University of Washington Medical Center

Seattle, Washington, 91895, United States

Location

Related Publications (3)

  • 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.

    PMID: 22516392RESULT

  • 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.

    PMID: 31185735DERIVED

  • 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.

    PMID: 30878475DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • J. Aaron Grantham, MD

    Saint Luke's Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

January 3, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

US(11)