STAR and Deferred Stenting Study

Coronary Stenosis Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089864
• Other study ID #: 21-122
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2023
• Source: Saint Luke's Health System
• Contact: Nancy Stone, MEd, NBC-HWC
• Phone: 816-932-5367
• Email: nanstone[@]saint-lukes.org
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Occlusion
• Coronary Restenosis
• Coronary Stenosis

Intervention

Other:
• Stent Placement Timing - Early
Stent placement 5-7 weeks after STAR procedure
• Stent Placement Timing - Late
Stent placement 12-14 weeks after STAR procedure

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Asahi-Intecc

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	14 weeks