Stent Placement Timing for Coronary Artery Disease
(STAR Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment Stent Placement Timing for Coronary Artery Disease?
Is stent placement timing generally safe for humans?
Research shows that both early and late stent placement in coronary artery disease patients have similar safety outcomes, with no significant differences in major adverse cardiac events. However, early stent placement may carry a slightly higher risk of recurrent heart attacks compared to late placement.12367
How does the timing of stent placement differ from other treatments for coronary artery disease?
The timing of stent placement for coronary artery disease can be early or late, with early placement occurring within a few weeks and late placement happening after a longer period. This approach is unique because it considers the optimal timing for stent placement to potentially improve outcomes, unlike standard treatments that may not focus on timing as a critical factor.13789
Eligibility Criteria
The STAR Study is for adults over 18 with chronic total occlusion in coronary arteries who are scheduled for a PCI procedure and have attempted the STAR technique. Participants must speak English and be able to do telephone follow-ups. Pregnant women, prisoners, those with severe kidney disease or dementia, hard of hearing individuals, and anyone already in another study cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Procedure
Participants undergo the STAR procedure for CTO-PCI
Early Stent Placement
Stent placement occurs 5-7 weeks post-STAR procedure
Later Stent Placement
Stent placement occurs 12-14 weeks post-STAR procedure
Follow-up
Participants are monitored for safety and effectiveness after stenting
Treatment Details
Interventions
- Stent Placement Timing - Early
- Stent Placement Timing - Late
Stent Placement Timing - Early is already approved in United States for the following indications:
- Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Saint Luke's Health System
Lead Sponsor
Asahi-Intecc
Collaborator