NCT05089864

Brief 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. Five sites will be selected to participate in STAR from a national network of highly experienced CTO-PCI centers across the United States.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 23, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed
Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

3.7 years

First QC Date

October 11, 2021

Last Update Submit

October 22, 2025

Conditions

Coronary OcclusionCoronary StenosisCoronary Restenosis

Keywords

chronic total occlusionsub-intimal plaque modification

Outcome Measures

Primary Outcomes (1)

  • 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%

    14 weeks

Secondary Outcomes (1)

  • Vessel patency at time of staged stenting procedure

    14 weeks

Study Arms (2)

Early stent placement

OTHER

Stent placement 5-7 weeks post-STAR procedure

Other: Stent Placement Timing - Early

Later stent placement

OTHER

Stent placement 12-14 weeks post-STAR procedure

Other: Stent Placement Timing - Late

Interventions

Stent Placement Timing - EarlyOTHER

Stent placement 5-7 weeks after STAR procedure

Early stent placement
Stent Placement Timing - LateOTHER

Stent placement 12-14 weeks after STAR procedure

Later stent placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (10)

  • 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.

    PMID: 29722796BACKGROUND

  • 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.

    PMID: 28797429BACKGROUND

  • 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.

    PMID: 22516392BACKGROUND

  • 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.

    PMID: 29068126BACKGROUND

  • 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.

    PMID: 32327084BACKGROUND

  • 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.

    PMID: 25442438BACKGROUND

  • 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.

    PMID: 30411863BACKGROUND

  • 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.

    PMID: 31797507BACKGROUND

  • 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.

    PMID: 41295935DERIVED

  • 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.

    PMID: 39044659DERIVED

MeSH Terms

Conditions

Coronary OcclusionCoronary StenosisCoronary Restenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

November 23, 2021

Primary Completion

August 7, 2025

Study Completion

August 7, 2025

Last Updated

October 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)