150 Participants Needed

Stent Placement Timing for Coronary Artery Disease

(STAR Trial)

NS
Overseen ByNancy Stone, MEd, NBC-HWC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Saint Luke's Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that early and late stent placement in heart attack patients have similar long-term outcomes, but early placement may have a higher risk of another heart attack. This suggests that timing can be flexible, but careful consideration is needed for early placement.12345

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

I am 18 years old or older.
I can communicate effectively in English.
My doctor tried a specific technique to treat my blocked artery and plans another procedure.
See 1 more

Exclusion Criteria

Incarcerated prisoner.
I am not pregnant, as confirmed by a hospital test.
Unable to participate in telephone follow-up
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Procedure

Participants undergo the STAR procedure for CTO-PCI

1 day
1 visit (in-person)

Early Stent Placement

Stent placement occurs 5-7 weeks post-STAR procedure

5-7 weeks
1 visit (in-person)

Later Stent Placement

Stent placement occurs 12-14 weeks post-STAR procedure

12-14 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stenting

14 weeks

Treatment Details

Interventions

  • Stent Placement Timing - Early
  • Stent Placement Timing - Late
Trial OverviewThis trial examines the timing of stent placement—either early or late—in patients undergoing a CTO-PCI procedure. It's a multi-center study involving 150 participants across the U.S., where they're randomly assigned to receive their stents at different times to see which is more effective.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Later stent placementExperimental Treatment1 Intervention
Stent placement 12-14 weeks post-STAR procedure
Group II: Early stent placementExperimental Treatment1 Intervention
Stent placement 5-7 weeks post-STAR procedure

Stent Placement Timing - Early is already approved in United States for the following indications:

🇺🇸
Approved in United States as Stent Placement Timing - Early for:
  • 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

Trials
42
Recruited
12,600+

Asahi-Intecc

Collaborator

Trials
1
Recruited
150+

Findings from Research

In a study of 115 stroke patients, early stenting (within 14 days of symptoms) was associated with a higher risk of long-term complications, including restenosis and recurrent ischemic strokes, compared to late stenting (after 14 days).
The early stenting group experienced more adverse events, with a total rate of ischemic strokes and other complications being significantly higher than in the late stenting group, indicating that timing of stenting may impact patient safety and outcomes.
Early versus delayed stenting for intracranial atherosclerotic artery stenosis with ischemic stroke.Zhang, Y., Sun, Y., Li, X., et al.[2020]
In a study of 268 STEMI patients undergoing PCI after 3 days of onset, early PCI (3-14 days) and late PCI (>14 days) showed comparable outcomes in terms of all-cause death and major adverse cardiac events, indicating similar efficacy of both timing strategies.
However, early PCI was associated with a significantly higher risk of recurrent myocardial infarction (MI), suggesting that while timing may not affect overall survival, it could influence the likelihood of subsequent heart issues.
Long-term outcomes of delayed percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction: A propensity score-matched retrospective study.Xue, YL., Ma, YT., Gao, YP., et al.[2023]
In a study of 1432 patients with acute coronary syndromes (ACS) undergoing staged percutaneous coronary intervention (PCI), early PCI (within 4 weeks) did not show a significant advantage over late PCI (4 weeks or more) in reducing major adverse cardiac events after one year.
Both early and late staged PCI resulted in similar rates of all-cause death, recurrent myocardial infarction, and the need for urgent non-target-vessel PCI, indicating that the timing of the procedure may not critically impact long-term outcomes.
Effect of Timing of Staged Percutaneous Coronary Intervention on Clinical Outcomes in Patients With Acute Coronary Syndromes.Otsuka, T., Bär, S., Losdat, S., et al.[2022]

References

Early versus delayed stenting for intracranial atherosclerotic artery stenosis with ischemic stroke. [2020]
Long-term outcomes of delayed percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction: A propensity score-matched retrospective study. [2023]
Effect of Timing of Staged Percutaneous Coronary Intervention on Clinical Outcomes in Patients With Acute Coronary Syndromes. [2022]
Optimal timing of staged percutaneous coronary intervention in ST-segment elevation myocardial infarction patients with multivessel disease. [2023]
[Long-term outcomes of patients with ST-elevation myocardial infarction undergoing early versus late delayed percutaneous coronary intervention using drug-eluting stents]. [2020]
Incidence of thrombotic occlusion and major adverse cardiac events between two and four weeks after coronary stent placement: analysis of 5,678 patients with a four-week ticlopidine regimen. [2019]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Results of intracoronary stenting made in different periods after diagnostic coronary angiography]. [2006]
Very Late Stent Thrombosis 11 Years after Implantation of a Drug-Eluting Stent. [2018]
Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. [2022]