STAR and Deferred Stenting Study (STAR)

October 22, 2025 updated by: Saint Luke's Health System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.
  2. Subject is ≥ 18 years of age at the time of consent
  3. 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.
  4. English speaking due to follow up.

Exclusion Criteria:

  1. The CTO segment is in a graft.
  2. Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.

  3. Unable to participate in telephone follow-up

    1. Too hard of hearing to do follow-up by telephone or deaf.
    2. Incarcerated prisoner.
    3. History of dementia.
    4. Subjects without a way for contact by telephone for follow-up.
  4. Previously enrolled in STAR.
  5. Patient not a candidate for baseline and final angiography (CKD with eGFR<30).
  6. The knuckled guidewire did not cross into the CTO segment during STAR attempt.
  7. A stent was placed into the STAR segment during the Index Procedure.
  8. Refused participation in the study.
  9. Patient enrolled in another study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Early stent placement
Stent placement 5-7 weeks post-STAR procedure
Other: Stent Placement Timing - Early
Stent placement 5-7 weeks after STAR procedure
Other: Later stent placement
Stent placement 12-14 weeks post-STAR procedure
Other: Stent Placement Timing - Late
Stent placement 12-14 weeks after STAR procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staged Procedure Success
Time Frame: 14 weeks
success of the staged stenting procedure will be core lab adjudicated and defined as TIMI 3 flow, no major side branch loss, and residual stenosis <30%
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vessel patency at time of staged stenting procedure
Time Frame: 14 weeks
number of distal branches, and the antegrade TIMI flow through the vessel, assessed by core-lab analysis
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Collaborators

Asahi-Intecc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2021

Primary Completion (Actual)

August 7, 2025

Study Completion (Actual)

August 7, 2025

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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