Coronary Artery DiseaseOPEN-CTONCT02026466
Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
An observational study of Coronary Artery Disease, run by Saint Luke's Health System at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,000 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2013to Dec 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 or older with CAD and at least one chronic total occluded vessel.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Presbyterian Health System Hospital
Albuquerque, New Mexico, 87106
Boone Hospital Center
Columbia, Missouri, 65201
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Banner Heart Hospital
Mesa, Arizona, 85206
Columbia University Medical Center
New York, New York, 10032
Banner Good Samaritan
Phoenix, Arizona, 85006
University of Washington Medical Center
Seattle, Washington, 91895
Peace Health Sacred Heart River Bend Medical Center
Springfield, Oregon, 94777
Torrance Memorial Medical Center
Torrance, California, 90505
York Hospital
York, Pennsylvania, 17405
About this study
Official title: Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Chronic Total Occlusion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (1)
Safety and Effectiveness
Describe safety and effectiveness among patients receiving CTO-PCI
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- J. Aaron Grantham, MD, Principal investigator, Saint Luke's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026466
- Sponsor's protocol ID
- OPEN CTO V1.2
- Acronym
- OPEN-CTO
- Status last verified
- Oct 2021
- First submitted
- 26 Nov 2013
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22516392Hirai 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.
PubMed 31185735Yeh 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.
PubMed 30878475
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
- ClinicalTrials.gov ID
- NCT02026466
- Acronym / sponsor ID
- OPEN-CTO / OPEN CTO V1.2
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Chronic Total Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Dec 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 or older with CAD and at least one chronic total occluded vessel.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Safety and Effectiveness
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Results publication: PubMed 22516392Brilakis 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.
- Derived from this study: PubMed 31185735Hirai 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.
- Derived from this study: PubMed 30878475Yeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Aaron Grantham, MD principal investigator
Saint Luke's Health System
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Saint Luke's Health System at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02026466, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.