Coronary OcclusionSTARNCT05089864

STAR and Deferred Stenting Study

A study testing Stent Placement Timing - Early and Stent Placement Timing - Late in people with Coronary Occlusion and Coronary Stenosis, run by Saint Luke's Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
What is being tested?: Stent Placement Timing - Early and Stent Placement Timing - Late
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: 23 Nov 2021to 7 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

The CTO segment is in a graft.
Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
Unable to participate in telephone follow-up
Too hard of hearing to do follow-up by telephone or deaf.
Incarcerated prisoner.
History of dementia.

Show all 13Show fewer

Subjects without a way for contact by telephone for follow-up.
Previously enrolled in STAR.
Patient not a candidate for baseline and final angiography (CKD with eGFR<30).
The knuckled guidewire did not cross into the CTO segment during STAR attempt.
A stent was placed into the STAR segment during the Index Procedure.
Refused participation in the study.
Patient enrolled in another study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111

Other trials in United States

About this study

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

Read the 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
Being tested: Stent Placement Timing - Early, Stent Placement Timing - Late
Keywords: chronic total occlusion, sub-intimal plaque modification
Medical subject headings: Coronary Occlusion, Coronary Stenosis, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stent Placement Timing - EarlyOther
Stent placement 5-7 weeks after STAR procedure
Stent Placement Timing - LateOther
Stent placement 12-14 weeks after STAR procedure

Study groups in NCT05089864
Study group	Role	What they receive
Early stent placement	Other	Stent placement 5-7 weeks post-STAR procedure Receives: Other: Stent Placement Timing - Early
Later stent placement	Other	Stent placement 12-14 weeks post-STAR procedure Receives: Other: Stent Placement Timing - Late

What is being measured

The primary outcome is the main question the study is designed to answer.

Staged Procedure Success
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%
Measured: 14 weeks

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 20217 Aug 2025

First posted22 Oct 2021
Study start23 Nov 2021
Primary completion7 Aug 2025
Study completion7 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Coronary OcclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05089864
Sponsor's protocol ID: 21-122
Acronym: STAR
Status last verified: Oct 2025
First submitted: 11 Oct 2021
Last updated: 24 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220.
PubMed 29722796
Sapontis J, Salisbury AC, Yeh RW, Cohen DJ, Hirai T, Lombardi W, McCabe JM, Karmpaliotis D, Moses J, Nicholson WJ, Pershad A, Wyman RM, Spaedy A, Cook S, Doshi P, Federici R, Thompson CR, Marso SP, Nugent K, Gosch K, Spertus JA, Grantham JA. Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty: A Report From the OPEN-CTO Registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures). JACC Cardiovasc Interv. 2017 Aug 14;10(15):1523-1534. doi: 10.1016/j.jcin.2017.05.065.
PubMed 28797429
Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.
PubMed 22516392
Hirai T, Grantham JA, Sapontis J, Cohen DJ, Marso SP, Lombardi W, Karmpaliotis D, Moses J, Nicholson WJ, Pershad A, Wyman RM, Spaedy A, Cook S, Doshi P, Federici R, Nugent K, Gosch KL, Spertus JA, Salisbury AC; OPEN CTO Study Group. Impact of subintimal plaque modification procedures on health status after unsuccessful chronic total occlusion angioplasty. Catheter Cardiovasc Interv. 2018 May 1;91(6):1035-1042. doi: 10.1002/ccd.27380. Epub 2017 Oct 25.
PubMed 29068126
Hirai T, Grantham JA, Gosch KL, Patterson C, Kirtane AJ, Lombardi W, Nicholson WJ, Moses J, Karmpaliotis D, Salisbury AC. Impact of Subintimal or Plaque Modification on Repeat Chronic Total Occlusion Angioplasty Following an Unsuccessful Attempt. JACC Cardiovasc Interv. 2020 Apr 27;13(8):1010-1012. doi: 10.1016/j.jcin.2020.01.214. No abstract available.
PubMed 32327084
Galassi AR, Boukhris M, Tomasello SD, Marza F, Azzarelli S, Giubilato S, Khamis H. Long-term clinical and angiographic outcomes of the mini-STAR technique as a bailout strategy for percutaneous coronary intervention of chronic total occlusion. Can J Cardiol. 2014 Nov;30(11):1400-6. doi: 10.1016/j.cjca.2014.07.016. Epub 2014 Jul 22.
PubMed 25442438
Goleski PJ, Nakamura K, Liebeskind E, Salisbury AC, Grantham JA, McCabe JM, Lombardi WL. Revascularization of coronary chronic total occlusions with subintimal tracking and reentry followed by deferred stenting: Experience from a high-volume referral center. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):191-198. doi: 10.1002/ccd.27783. Epub 2018 Nov 9.
PubMed 30411863
Xenogiannis I, Choi JW, Alaswad K, Khatri JJ, Doing AH, Dattilo P, Jaffer FA, Uretsky B, Krestyaninov O, Khelimskii D, Patel M, Mahmud E, Potluri S, Koutouzis M, Tsiafoutis I, Jaber W, Samady H, Jefferson BK, Patel T, Megaly MS, Hall AB, Vemmou E, Nikolakopoulos I, Rangan BV, Abdullah S, Garcia S, Banerjee S, Burke MN, Brilakis ES. Outcomes of subintimal plaque modification in chronic total occlusion percutaneous coronary intervention. Catheter Cardiovasc Interv. 2020 Nov;96(5):1029-1035. doi: 10.1002/ccd.28614. Epub 2019 Dec 4.
PubMed 31797507
Azzalini L, Kearney K, Salisbury AC, Stone N, Gosch KL, Jones PG, Spertus JA, Pershad A, Nicholson W, Lombardi W, Wyman RM, Davies R, Grantham JA, Hirai T; STAR Study Group. Early vs Late Staged PCI After Subintimal Tracking and Re-Entry for Chronic Total Occlusions: A Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):286-293. doi: 10.1016/j.jacc.2025.09.1598. Epub 2025 Nov 26.
PubMed 41295935
Hirai T, Kearney K, Azzalini L, Salisbury AC, Stone N, Gosch KL, Pershad A, Nicholson W, Lombardi W, Wyman RM, Davies R, Grantham JA; STAR Study Group. Optimal timing of staged percutaneous coronary intervention after subintimal tracking and re-entry: Rationale and design of the subintimal tracking and re-entry with deferred stenting study. Catheter Cardiovasc Interv. 2024 Sep;104(3):444-450. doi: 10.1002/ccd.31161. Epub 2024 Jul 24.
PubMed 39044659

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Occlusion trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcomes and Safety in Patients Treated With STAR and Deferred Stenting After Unsuccessful CTO PCI
ClinicalTrials.gov ID: NCT05089864
Acronym / sponsor ID: STAR / 21-122
Conditions: Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
Keywords: chronic total occlusion, sub-intimal plaque modification
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Saint Luke's Health SystemUniversity, hospital or other
Collaborators: Asahi-Intecc
Study start: 23 Nov 2021 (actual)
Primary completion: 7 Aug 2025 (actual)
Study completion: 7 Aug 2025 (actual)
First posted: 22 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Early stent placement	Other	Other: Stent Placement Timing - EarlyStent placement 5-7 weeks post-STAR procedure
Later stent placement	Other	Other: Stent Placement Timing - LateStent placement 12-14 weeks post-STAR procedure

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

The CTO segment is in a graft.
Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
Unable to participate in telephone follow-up
Previously enrolled in STAR.
Patient not a candidate for baseline and final angiography (CKD with eGFR<30).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stent Placement Timing - EarlyStent placement 5-7 weeks after STAR procedure	Other	Early stent placement
Stent Placement Timing - LateStent placement 12-14 weeks after STAR procedure	Other	Later stent placement

Primary outcome

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%

1 secondary outcome

Vessel patency at time of staged stenting procedure
Time frame: 14 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
Background: PubMed 29722796Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220.
Background: PubMed 28797429Sapontis J, Salisbury AC, Yeh RW, Cohen DJ, Hirai T, Lombardi W, McCabe JM, Karmpaliotis D, Moses J, Nicholson WJ, Pershad A, Wyman RM, Spaedy A, Cook S, Doshi P, Federici R, Thompson CR, Marso SP, Nugent K, Gosch K, Spertus JA, Grantham JA. Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty: A Report From the OPEN-CTO Registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures). JACC Cardiovasc Interv. 2017 Aug 14;10(15):1523-1534. doi: 10.1016/j.jcin.2017.05.065.
Background: PubMed 22516392Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.
Background: PubMed 29068126Hirai T, Grantham JA, Sapontis J, Cohen DJ, Marso SP, Lombardi W, Karmpaliotis D, Moses J, Nicholson WJ, Pershad A, Wyman RM, Spaedy A, Cook S, Doshi P, Federici R, Nugent K, Gosch KL, Spertus JA, Salisbury AC; OPEN CTO Study Group. Impact of subintimal plaque modification procedures on health status after unsuccessful chronic total occlusion angioplasty. Catheter Cardiovasc Interv. 2018 May 1;91(6):1035-1042. doi: 10.1002/ccd.27380. Epub 2017 Oct 25.
Background: PubMed 32327084Hirai T, Grantham JA, Gosch KL, Patterson C, Kirtane AJ, Lombardi W, Nicholson WJ, Moses J, Karmpaliotis D, Salisbury AC. Impact of Subintimal or Plaque Modification on Repeat Chronic Total Occlusion Angioplasty Following an Unsuccessful Attempt. JACC Cardiovasc Interv. 2020 Apr 27;13(8):1010-1012. doi: 10.1016/j.jcin.2020.01.214. No abstract available.
Background: PubMed 25442438Galassi AR, Boukhris M, Tomasello SD, Marza F, Azzarelli S, Giubilato S, Khamis H. Long-term clinical and angiographic outcomes of the mini-STAR technique as a bailout strategy for percutaneous coronary intervention of chronic total occlusion. Can J Cardiol. 2014 Nov;30(11):1400-6. doi: 10.1016/j.cjca.2014.07.016. Epub 2014 Jul 22.
Background: PubMed 30411863Goleski PJ, Nakamura K, Liebeskind E, Salisbury AC, Grantham JA, McCabe JM, Lombardi WL. Revascularization of coronary chronic total occlusions with subintimal tracking and reentry followed by deferred stenting: Experience from a high-volume referral center. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):191-198. doi: 10.1002/ccd.27783. Epub 2018 Nov 9.
Background: PubMed 31797507Xenogiannis I, Choi JW, Alaswad K, Khatri JJ, Doing AH, Dattilo P, Jaffer FA, Uretsky B, Krestyaninov O, Khelimskii D, Patel M, Mahmud E, Potluri S, Koutouzis M, Tsiafoutis I, Jaber W, Samady H, Jefferson BK, Patel T, Megaly MS, Hall AB, Vemmou E, Nikolakopoulos I, Rangan BV, Abdullah S, Garcia S, Banerjee S, Burke MN, Brilakis ES. Outcomes of subintimal plaque modification in chronic total occlusion percutaneous coronary intervention. Catheter Cardiovasc Interv. 2020 Nov;96(5):1029-1035. doi: 10.1002/ccd.28614. Epub 2019 Dec 4.
Derived from this study: PubMed 41295935Azzalini L, Kearney K, Salisbury AC, Stone N, Gosch KL, Jones PG, Spertus JA, Pershad A, Nicholson W, Lombardi W, Wyman RM, Davies R, Grantham JA, Hirai T; STAR Study Group. Early vs Late Staged PCI After Subintimal Tracking and Re-Entry for Chronic Total Occlusions: A Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):286-293. doi: 10.1016/j.jacc.2025.09.1598. Epub 2025 Nov 26.
Derived from this study: PubMed 39044659Hirai T, Kearney K, Azzalini L, Salisbury AC, Stone N, Gosch KL, Pershad A, Nicholson W, Lombardi W, Wyman RM, Davies R, Grantham JA; STAR Study Group. Optimal timing of staged percutaneous coronary intervention after subintimal tracking and re-entry: Rationale and design of the subintimal tracking and re-entry with deferred stenting study. Catheter Cardiovasc Interv. 2024 Sep;104(3):444-450. doi: 10.1002/ccd.31161. Epub 2024 Jul 24.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stent Placement Timing - Early and Stent Placement Timing - Late in people with Coronary Occlusion and Coronary Stenosis, run by Saint Luke's Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Staged Procedure Success (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05089864, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.