← Back to Search

Procedure

Stent Placement Timing for Coronary Artery Disease (STAR Trial)

N/A

Recruiting

Research Sponsored by Saint Luke's Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is ≥ 18 years of age at the time of consent

English speaking due to follow up.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks

Awards & highlights

STAR Trial Summary

This trial is testing a new way to do a heart procedure on 150 people to see if it's safe and effective.

Who is the study for?

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.Check my eligibility

What is being tested?

This 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.See study design

What are the potential side effects?

While not explicitly listed here, typical side effects from procedures like CTO-PCI can include bleeding at the catheter insertion site, infection, allergic reactions to contrast dye used during angiography, heart attack or stroke risks due to clots dislodged during stenting.

STAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I can communicate effectively in English.

Select...

My doctor tried a specific technique to treat my blocked artery and plans another procedure.

Select...

I am scheduled for a procedure to open a completely blocked heart artery.

STAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Staged Procedure Success

Secondary outcome measures

Vessel patency at time of staged stenting procedure

STAR Trial Design

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Saint Luke's Health SystemLead Sponsor

41 Previous Clinical Trials

12,796 Total Patients Enrolled

Asahi-InteccUNKNOWN

Media Library

Stent Placement Timing - Early (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05089864 — N/A

Coronary Artery Stenosis Research Study Groups: Early stent placement, Later stent placement

Coronary Artery Stenosis Clinical Trial 2023: Stent Placement Timing - Early Highlights & Side Effects. Trial Name: NCT05089864 — N/A

Stent Placement Timing - Early (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05089864 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants recruited for this research?

"Confirmatively, clinicaltrials.gov lists this trial as actively recruiting patients. The study was initially posted on November 23rd 2021 and last updated December 21st of the same year; 150 people are sought from one centre."

Answered by AI

Are researchers still accepting volunteers for this experiment?

"Affirmative. According to clinicaltrials.gov, this scientific experiment has been looking for participants since November 23rd 2021 and is still actively recruiting as of December 21st 2021. The trial aims to enlist 150 individuals from a single medical site."

Answered by AI

Recent research and studies

Catheterization and Cardiovascular InterventionsJournal

Impact of Subintimal Plaque Modification Procedures on Health Status After Unsuccessful Chronic Total Occlusion Angioplasty

Hirai, Taishi, J. Aaron Grantham, James Sapontis, David J. Cohen, Steven P. Marso, William Lombardi, Dimitri Karmpaliotis, et al.. 2017. “Impact of Subintimal Plaque Modification Procedures on Health Status After Unsuccessful Chronic Total Occlusion Angioplasty”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.27380.

Catheterization and Cardiovascular InterventionsJournal

Revascularization of Coronary Chronic Total Occlusions with Subintimal Tracking and Reentry Followed by Deferred Stenting: Experience from a High‐volume Referral Center

Goleski, Patrick J., Kenta Nakamura, Emily Liebeskind, Adam C. Salisbury, J. Aaron Grantham, James M. McCabe, and William L. Lombardi. 2018. “Revascularization of Coronary Chronic Total Occlusions with Subintimal Tracking and Reentry Followed by Deferred Stenting: Experience from a High‐volume Referral Center”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.27783.

JACC: Cardiovascular InterventionsJournal

Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty

Sapontis, James, Adam C. Salisbury, Robert W. Yeh, David J. Cohen, Taishi Hirai, William Lombardi, James M. McCabe, et al.. 2017. “Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2017.05.065.

Canadian Journal of CardiologyJournal