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OpenTrials
Completed

NCT Number: NCT02026466

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner Heart Hospital, Mesa, Arizona, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Health Status

    Time frame: One year

    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.

Secondary outcomes

  1. Safety and Effectiveness

    Time frame: One Year

    Describe safety and effectiveness among patients receiving CTO-PCI

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: OPEN-CTO

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 3, 2014
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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