STAR and Deferred Stenting Study

Sponsor

Saint Luke's Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT05089864

Collaborator

Asahi-Intecc (Other)

150

Enrollment

Location

Arms

43.2

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Occlusion Coronary Stenosis Coronary Restenosis	Other: Stent Placement Timing - Early Other: Stent Placement Timing - Late	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 23, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Staged Procedure Success [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%

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111

Sponsors and Collaborators

Saint Luke's Health System
Asahi-Intecc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Saint Luke's Health System

ClinicalTrials.gov Identifier:

NCT05089864

Other Study ID Numbers:

21-122

First Posted:

Oct 22, 2021

Last Update Posted:

Jan 11, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Saint Luke's Health System

chronic total occlusion

sub-intimal plaque modification

Additional relevant MeSH terms:

Coronary Stenosis

Coronary Occlusion

Coronary Restenosis

Study Results

No Results Posted as of Jan 11, 2022