NCT05089864Completed
STAR and Deferred Stenting Study
Outcomes and Safety in Patients Treated With STAR and Deferred Stenting After Unsuccessful CTO PCI
Source: ClinicalTrials.gov · Last updated 24 Oct 2025
Brief summary (registry, in English)
STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a prospective, multi-center study of 150 participants with randomization of timing of staged PCI. Five sites will be selected to participate in STAR from a national network of highly experienced CTO-PCI centers across the United States.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 11 Oct 2021
- Start date
- 23 Nov 2021
- Primary completion date
- 7 Aug 2025
- Lead sponsor
- Saint Luke's Health System
- Diseases
- Coronary artery disease
- NCT number
- NCT05089864
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 23 Nov 2021 to the primary completion date, 7 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously enrolled in STAR.
Other illness
- Unable to participate in telephone follow-up
- Too hard of hearing to do follow-up by telephone or deaf.
- Incarcerated prisoner.
- History of dementia.
- Subjects without a way for contact by telephone for follow-up.
Lab values
- Patient not a candidate for baseline and final angiography (CKD with eGFR\<30).
Other
- The CTO segment is in a graft.
- Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
- The knuckled guidewire did not cross into the CTO segment during STAR attempt.
- A stent was placed into the STAR segment during the Index Procedure.
- Refused participation in the study.
- Patient enrolled in another study.
Who the study is looking for
- 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
- The operator attempted STAR technique defined as knuckle guidewire across or into the CTO segment during the CTO PCI and is planned for a staged procedure.
- English speaking due to follow up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.