Coronary Stenosis Clinical Trial
— STAROfficial title:
Outcomes and Safety in Patients Treated With STAR and Deferred Stenting After Unsuccessful CTO PCI
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 | Recruiting |
Enrollment | 150 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero. 2. Subject is = 18 years of age at the time of consent 3. 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. 4. English speaking due to follow up. Exclusion Criteria: 1. The CTO segment is in a graft. 2. Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy. 3. Unable to participate in telephone follow-up 1. Too hard of hearing to do follow-up by telephone or deaf. 2. Incarcerated prisoner. 3. History of dementia. 4. Subjects without a way for contact by telephone for follow-up. 4. Previously enrolled in STAR. 5. Patient not a candidate for baseline and final angiography (CKD with eGFR<30). 6. The knuckled guidewire did not cross into the CTO segment during STAR attempt. 7. A stent was placed into the STAR segment during the Index Procedure. 8. Refused participation in the study. 9. Patient enrolled in another study. |
Country | Name | City | State |
---|---|---|---|
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Saint Luke's Health System | Asahi-Intecc |
United States,
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Goleski PJ, Nakamura K, Liebeskind E, Salisbury AC, Grantham JA, McCabe JM, Lombardi WL. Revascularization of coronary chronic total occlusions with subintimal tracking and reentry followed by deferred stenting: Experience from a high-volume referral center. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):191-198. doi: 10.1002/ccd.27783. Epub 2018 Nov 9. — View Citation
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Sapontis J, Salisbury AC, Yeh RW, Cohen DJ, Hirai T, Lombardi W, McCabe JM, Karmpaliotis D, Moses J, Nicholson WJ, Pershad A, Wyman RM, Spaedy A, Cook S, Doshi P, Federici R, Thompson CR, Marso SP, Nugent K, Gosch K, Spertus JA, Grantham JA. Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty: A Report From the OPEN-CTO Registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures). JACC Cardiovasc Interv. 2017 Aug 14;10(15):1523-1534. doi: 10.1016/j.jcin.2017.05.065. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Staged Procedure Success | success of the staged stenting procedure will be core lab adjudicated and defined as TIMI 3 flow, no major side branch loss, and residual stenosis <30% | 14 weeks | |
Secondary | Vessel patency at time of staged stenting procedure | number of distal branches, and the antegrade TIMI flow through the vessel, assessed by core-lab analysis | 14 weeks |
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