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STAR and Deferred Stenting Study

NCT05089864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-24

No results posted yet for this study

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.

Conditions

  • Coronary Occlusion
  • Coronary Stenosis
  • Coronary Restenosis

Interventions

OTHER

Stent Placement Timing - Early

Stent placement 5-7 weeks after STAR procedure

OTHER

Stent Placement Timing - Late

Stent placement 12-14 weeks after STAR procedure

Sponsors & Collaborators

  • Asahi-Intecc

    collaborator UNKNOWN

  • Saint Luke's Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2025-08-07
Completion
2025-08-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089864 on ClinicalTrials.gov