NCT05089864

STAR and Deferred Stenting Study

Outcomes and Safety in Patients Treated With STAR and Deferred Stenting After Unsuccessful CTO PCI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Saint Luke's Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To date, there have been no studies that prospectively and systemically evaluated the efficacy and safety of STAR with deferred stenting and described the frequency of its use in the hybrid approach. The aim of this study is to address these current gaps in knowledge, including the frequency of use of STAR by experienced operators, the safety of its use, optimal timing of staged stenting and health status change associated with this procedure. This prospective study will enroll 150 patients undergoing elective PCI of native CTO utilizing the STAR technique and will subsequently randomize patients in a 1:1 fashion to early (5-7 weeks) and later (12-14 weeks) timing of subsequent stenting.

Conditions

• Coronary Occlusion
• Coronary Stenosis
• Coronary Restenosis

Interventions

Type	Name	Description
OTHER	Stent Placement Timing - Early	Stent placement 5-7 weeks after STAR procedure
OTHER	Stent Placement Timing - Late	Stent placement 12-14 weeks after STAR procedure

Timeline

• Start date: 2021-11-23
• Primary completion: 2025-08-07
• Completion: 2025-08-07
• First posted: 2021-10-22
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States