CompletedNot Applicable

STAR and Deferred Stenting Study

United States150 participantsStarted 2021-11-23

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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
✓. 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.

Exclusion criteria

✕. The CTO segment is in a graft.
✕. Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
✕. 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.
✕. Previously enrolled in STAR.

What they're measuring

Staged Procedure Success

Timeframe: 14 weeks

Trial details

NCT IDNCT05089864

SponsorSaint Luke's Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-07

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