Back to resultsSTAR and Deferred Stenting Study (STAR)
Primary Purpose
Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stent Placement Timing - Early
Stent Placement Timing - Late
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Occlusion focused on measuring chronic total occlusion, sub-intimal plaque modification
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Saint Luke's Hospital of Kansas CityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Early stent placement
Later stent placement
Arm Description
Stent placement 5-7 weeks post-STAR procedure
Stent placement 12-14 weeks post-STAR procedure
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05089864
First Posted
October 11, 2021
Last Updated
April 10, 2023
Sponsor
Saint Luke's Health System
Collaborators
Asahi-Intecc
1. Study Identification
Unique Protocol Identification Number
NCT05089864
Brief Title
STAR and Deferred Stenting Study
Acronym
STAR
Official Title
Outcomes and Safety in Patients Treated With STAR and Deferred Stenting After Unsuccessful CTO PCI
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Luke's Health System
Collaborators
Asahi-Intecc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
Keywords
chronic total occlusion, sub-intimal plaque modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early stent placement
Arm Type
Other
Arm Description
Stent placement 5-7 weeks post-STAR procedure
Arm Title
Later stent placement
Arm Type
Other
Arm Description
Stent placement 12-14 weeks post-STAR procedure
Intervention Type
Other
Intervention Name(s)
Stent Placement Timing - Early
Intervention Description
Stent placement 5-7 weeks after STAR procedure
Intervention Type
Other
Intervention Name(s)
Stent Placement Timing - Late
Intervention Description
Stent placement 12-14 weeks after STAR procedure
Primary Outcome Measure Information:
Title
Staged Procedure Success
Description
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%
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Vessel patency at time of staged stenting procedure
Description
number of distal branches, and the antegrade TIMI flow through the vessel, assessed by core-lab analysis
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Stone, MEd, NBC-HWC
Phone
816-932-5367
Email
nanstone@saint-lukes.org
Facility Information:
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Stone, MS
Phone
816-932-5989
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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29722796
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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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.
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Results Reference
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STAR and Deferred Stenting Study
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